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87 Study Matches

A Treatment Study of ACH-0144471 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) With Inadequate Response to Eculizumab (PNH)

To determine the effectiveness of ACH-0144471 in improving anemia when given with eculizumab for 24 weeks in patients with PNH.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Ibrahim Ibrahim
61675
All
18 Years to 65 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03472885
STU-2020-0194
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Key
Inclusion Criteria:

• Diagnosed with PNH
• 18 to 65 years of age
• Have received at least one RBC transfusion within last 12 weeks
• Anemia with adequate reticulocytosis
• Must be on a stable regimen of eculizumab
• Platelet count ≥ 40,000/μL without the need for platelet transfusions
• Documentation of vaccination for N. meningitidis, H. influenza, and S. pneumoniae or willingness to receive vaccinations based on local guidelines
• Willingness to receive antibiotic prophylaxis
• Female participants must use highly effective birth control to prevent pregnancy during the clinical trial and for 30 days after their last dose of study drug.
• Male participants must use a highly effective birth control with a female partner to prevent pregnancy during the clinical trial and for 90 days after the last dose of study drug. Key
Exclusion Criteria:

• Current evidence of bone marrow failure or aplastic anemia requiring treatment
• History of a major organ transplant or hematopoietic stem cell/marrow transplant
• Received another investigational agent within 30 days or 5 half-lives of the investigational agent prior to study entry, whichever is greater
• Documented C5 mutations
• Known or suspected complement deficiency
• Contraindication to any of the required vaccinations
• Active bacterial infection or clinically significant active viral infection, a body temperature >38°C, or other evidence of infection
• History of meningococcal infection, or a first-degree relative or household contact with a history of meningococcal infection
• History of hypersensitivity reactions to commonly used antibacterial agents NOTE: Additional inclusion/exclusion criteria may apply, per protocol.
Drug: ACH-0144471, Drug: Eculizumab
Paroxysmal Nocturnal Hemoglobinuria (PNH), Cardiovascular
PNH, Paroxysmal Nocturnal Hemoglobinuria, ACH-0144471, eculizumab
UT Southwestern
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A Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids, in Subjects With Non-ambulatory Duchenne Muscular Dystrophy (DMD)

To evaluate the efficacy and safety of pamrevlumab versus placebo in combination with systemic corticosteroids in subjects with non-ambulatory Duchenne muscular dystrophy (age 12 years and older).
Call 214-648-5005
studyfinder@utsouthwestern.edu
Diana Castro
102470
Male
12 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04371666
STU-2020-0249
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Inclusion Criteria:
1. Males at least 12 years of age, non-ambulatory at screening initiation 2. Written consent by patient and/or legal guardian as per regional/ country and/or IRB/IEC requirements 3. Male subjects with partners of childbearing potential must use contraception during the conduct of the study, and for 3 months after the last dose of study drug. 4. Medical history includes diagnosis of DMD and confirmed Duchenne mutation using a validated genetic test 5. Brooke Score for Arms and Shoulders ≤5 6. Able to undergo MRI test for the upper arm extremities (Biceps Brachii muscle) and cardiac muscle 7. Able to perform spirometry 8. Average (of Screening and Day 0) percent predicted FVC between 45 and 85, inclusive 9. Left ventricular ejection fraction ≥50% as determined by cardiac MRI at screening or within 3 months prior to randomization (Day 0) 10. Prior diagnosis of cardiomyopathy, subjects must be on a stable regimen dose for cardiomyopathy/ heart failure medications (e.g., angiotensin converting enzyme inhibitors, aldosterone receptors blockers, angiotensin-receptor blockers, and betablockers) for at least 1 month prior to screening 11. On a stable dose of systemic corticosteroids for a minimum of 6 months, with no substantial change in dosage for a minimum of 3 months (except for adjustments for changes in body weight) prior to screening. Corticosteroid dosage should be in compliance with the DMD Care Considerations Working Group recommendations (e.g.prednisone or prednisolone 0.75 mg/kg per day or deflazacort 0.9 mg/kg per day) or stable dose. A reasonable expectation is that dosage and dosing regimen would not change significantly for the duration of the study. 12. Received pneumococcal vaccine (PPSV23) (or any other pneumococcal polysaccharide vaccine as per national recommendations) and is receiving annual influenza vaccinations 13. Adequate renal function: cystatin C ≤1.4 mg/L 14. Adequate hematology and electrolytes parameters: 1. Platelets >100,000/mcL 2. Hemoglobin >12 g/dL 3. Absolute neutrophil count >1500 /μL 4. Serum calcium (Ca), potassium (K), sodium (Na), magnesium (Mg) and phosphorus (P) levels are within a clinically accepted range 15. Adequate hepatic function: 1. No history or evidence of liver disease 2. Gamma glutamyl transferase (GGT) ≤3x upper limit of normal (ULN) 3. Total bilirubin ≤1.5xULN
Exclusion Criteria:
1. Previous exposure to pamrevlumab 2. BMI ≥40 kg/m2 or weight >117 kg 3. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies 4. Exposure to any investigational drug (for DMD or not), in the 30 days prior to screening initiation or use of approved DMD therapies (e.g., eteplirsen, ataluren, golodirsen) within 5 half-lives of screening, whichever is longer, with the exception of the systemic corticosteroids, including deflazacort 5. Severe uncontrolled heart failure (NYHA Classes III-IV), including any of the following: 1. Need for intravenous diuretics or inotropic support within 8 weeks prior to screening 2. Hospitalization for a heart failure exacerbation or arrhythmia within 8 weeks prior to screening 6. Arrhythmia requiring anti-arrhythmic therapy 7. Requires ≥16 hours continuous ventilation 8. Hospitalization due to respiratory failure within the 8 weeks prior to screening 9. Poorly controlled asthma or underlying lung disease such as bronchitis, bronchiectasis,emphysema, recurrent pneumonia that in the opinion of the investigator might impact respiratory function 10. The Investigator judges that the subject will be unable to fully participate in the study and complete it for any reason, including inability to comply with study procedures and treatment, or any other relevant medical or psychiatric conditions
Drug: Pamrevlumab, Drug: Placebo
Duchenne Muscular Dystrophy, Other, Cardiovascular
Duchenne Muscular Dystrophy, DMD
Children’s Health
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SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy

This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15 AHPJ-505) as a replacement device for pediatric patients with a diseased, damaged, or malfunctioning aortic valve.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Robert Jaquiss
171960
All
Not specified
This study is NOT accepting healthy volunteers
NCT03924661
STU-2020-1194
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Inclusion Criteria:

• Inclusion criteria for prospectively enrolled subjects
• Subject's legal guardian must provide written informed consent prior to any clinical study related procedure.
• Subject requires aortic valve replacement and is intended to be implanted with a 15mm SJM15 AHPJ-505 MHV as determined by the implanting physician in accordance with the Instructions for Use.
• The legal guardian and site agree to follow the subject per the assessment schedule and complete all required assessments per this protocol for the duration of the clinical study.
• Inclusion criteria for retrospectively enrolled subjects : In an effort to ensure data on all real-world use conditions are consistently collected and reported on, a subject is eligible to participate in this post-approval study if he/she meets all of the following inclusion criteria and meets no exclusion criterion. For those subjects with a previous implant attempt to be eligible for study participation, the following inclusion criteria must be met:
• Echocardiography data at a time point greater than 90 days is available or may be acquired.
• An implant was attempted with the 15mm MHV, where implant attempt is defined as the device physically contacting the subject's cardiac anatomy.
• Either:
• For living subjects who already received the 15mm MHV, the legal guardian signs the study informed consent for this protocol allowing access to all relevant historical medical information, and complete all required assessments according to this protocol from the time of consent going forward (if applicable). OR
• For subjects who are deceased or explanted, an implantation with 15mm MHV was attempted and the subject's legal guardian provides written informed consent for retrospective data collection of patient and study valve related information through death or explant of the study device.
Exclusion Criteria:

• Exclusion criteria for prospectively enrolled subjects: Subject has a contraindication to anticoagulant/antiplatelet medication.
• Exclusion criteria of retrospectively enrolled subjects: None
Device: Aortic Valve Replacement
Heart, Aortic Valve Disease
Children’s Health
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Stereotactic Radiosurgery (SRS) for Brain Metastasis (SRS)

SRS dose escalation for brain metastases in radiation-naïve patients will establish true tolerable doses, which may exceed the current standard doses. This may lead to an improvement in local control, patient survival, and/or quality-of life.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Robert Timmerman
69821
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02645487
STU 022015-106
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Inclusion Criteria 1. Biopsy-proven non-hematopoietic malignancy, except for small cell lung cancer, germ cell cancer, or unknown primary tumor. 2. Radiographic evidence by MRI (or by CT scan with CT contrast if ineligible or intolerant of MRI) of brain metastasis. (If patient is unable to tolerate MRI contrast, an MRI without contrast is acceptable if lesions are visible) 3. All brain metastases must be outside the brain stem (midbrain, pons and medulla). 4. Patient must have 10 or less brain metastases. 5. The maximum diameter of any lesion must be less than or equal to 3.0 cm. 6. Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any targeted agents are allowed provided that:
• Radiation was not to the brain.
• Surgery to the brain was > 7 days prior to SRS and there remains at least one additional brain metastasis that can be targeted with SRS 7. Age ≥ 18 years. 8. ECOG Performance Score of 2 or better/Karnofsky Performance Status score of 50-60 or better. 9. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 10. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). Medically acceptable birth control (contraceptives) includes:
• Approved hormonal contraceptives (such as birth control pills, patch, or ring: Depo-Provera, Implanon), or
• Barrier methods (such as a condom or diaphragm) used with a spermicide (a substance that kills sperm) 11. Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria 1. Patients had craniotomy and surgery to the brain within 7 days from the date of SRS. 2. Patients with leptomeningeal metastasis. NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive CSF cytology and/or equivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion. 3. Patients with a contraindication to both MRI (with or without contrast) and CT scan (with contrast) 4. Patients with life expectancy < 3 months. 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements. 6. Subjects must not be pregnant or nursing at the time of SRS treatment due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Radiation: Stereotactic Radiosurgery
Brain Neoplasms, Adult, Malignant, Lymphoma, Sarcoma, Multiple Myeloma, Brain and Nervous System, Other, Eye and Orbit, Anklylosing Spondylitis, Anus, Bones and Joints, Breast - Female, Breast - Male, Cardiovascular, Cervix, Colon, Corpus Uteri, Ear, Esophagus, Gall Bladder, Head and Neck, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Liver, Lung/Thoracic, Melanoma, skin, Nose, Other Digestive Organ, Other Endocrine System, Other Female Genital, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Skin, Other Urinary, Ovary, Pancreas, Prostate, Rectum, Stomach, Throat, Thyroid, Urinary Bladder, Uterine (Endometrial), Vulva, Hodgkins Lymphoma, Lymphoid Leukemia, Small Intestine, Soft Tissue
Parkland Health & Hospital System
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Improving Chronic Disease Management With Pieces (ICD-Pieces)

ICD-Pieces (Parkland Intelligent e-Coordination and Evaluation System) trial is a National Institutes of Health (NIH) Healthcare Systems(HCS) Collaboratory demonstration project to improve management of patients with a triad of Chronic Kidney Disease, hypertension and diabetes with Pieces in four HCS including Parkland, Texas Health Resources (THR), ProHealth Physicians Incorporation and North Texas VA. Pieces is a decision support technology platform created by Parkland Center for Clinical Innovation(PCCI). The primary objective is to test the hypothesis that a collaborative model of primary care and subspecialty care intervention enhanced by Pieces and practice facilitators compared to standard clinical practice will reduce all-cause hospitalizations in patients with coexisting chronic kidney disease, diabetes and hypertension. Secondary objectives are: a)Test if implementation of the collaborative model will reduce 30-day readmissions, emergency room visits, cardiovascular events or deaths and disease-specific hospitalizations; b) Develop and validate risk predictive models for disease-specific hospitalizations, all-cause hospitalizations, 30-day readmissions, emergency room visits, cardiovascular events and deaths for patients with chronic kidney disease, diabetes and hypertension. c) Collect demographic and clinical data to assist phenotyping patients with chronic kidney disease, diabetes and hypertension. d) Obtain safety data including Acute Kidney Injury, progression of chronic kidney disease, electrolyte disturbances and medication errors, and drug toxicity; e) Collect resource utilization information including hospitalizations, emergency room visits, outpatient visits, and diagnostic or therapeutic procedures completed. Candidate patients in selected clinics will be enrolled over a period of 2 years and followed for 12 months. Pieces will ascertain both primary and secondary outcomes from the Electronic Health Record supported with data from the Dallas Fort Worth Hospital Council (DFWHC), Accountable Care Organization (ACO) reports and VA database, and deaths from Social Security Index (SSI) data.
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studyfinder@utsouthwestern.edu
Miguel Vazquez
17567
All
18 Years to 85 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02587936
STU 062015-016
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Inclusion Criteria
• CKD Inclusion Criteria (present at least ≥ 3 months apart) 1. There will be two or more Estimated Glomerular Filtration Rate (eGFRs) calculations less than 60ml/minute (corrected for BSA) or 2. Two or more positive tests for albuminuria and/or proteinuria Albuminuria/proteinuria can be defined by quantitative criteria with albumin/creatinine ratio greater than 30mg/g, urine protein creatinine ratio greater than 200mg/g or positive dipstick with protein detection (adjusted for urinary concentration/specific gravity).
• Diabetes Inclusion Criteria Only patients with type 2 diabetes will be enrolled in this study. 1. Random blood glucose greater than 200mg/dL 2. Hemoglobin A1C greater than 6.5% 3. Use of hypoglycemic agents or 4. Type 2 diabetes included in problem list
• Hypertension Inclusion Criteria 1. Systolic blood pressure greater than 140 mmHg on two different occasions at least one week apart 2. Diastolic blood pressure greater than 90 on two occasions at least more than one week apart 3. Use of antihypertensive agents except thiazide diuretics or 4. Hypertension included in problem list
Exclusion Criteria:

• Exclusion criteria will be minimal in this pragmatic trial. The collaborative model of care will not be implemented in patients younger than 18 years or older than 85 years of age or patients who have CKD stage 5/End Stage Renal Disease(ESRD.
• Primary care practitioners have the option of not implementing the intervention on any of their patients if they believe benefit to be minimal or risk too high due to patient comorbidities
Other: Collaborative Model of Primary care and Subspecialty care
Type 2 Diabetes, Hypertension, Chronic Kidney Disease, Diabetes, High BP
Chronic, Risk prediction model, Quality Improvement (QI), Pragmatic trial, Cluster randomization, Collaborative care, clinical informatics, Chronic kidney disease, hypertension, high BP, diabetes
Parkland Health & Hospital System
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Optimal Delay Time to Initiate Anticoagulation After Ischemic Stroke in Atrial Fibrillation (START)

Title: Optimal Delay Time to Initiate Anticoagulation after Ischemic Stroke in Atrial Fibrillation (START): a pragmatic, adaptive randomized clinical trial. Primary Objective: • To determine the optimal time to initiate anticoagulation with a Non-Vitamin K Oral Anticoagulant (NOAC) after ischemic stroke in patients with non-valvular atrial fibrillation. Secondary Objectives: - To compare the rates of primary adverse outcomes in a per protocol analysis - To compare 30 day clinical outcomes by the modified Rankin scale among the time-to-treatment groups - To compare 30 day clinical outcomes by the PROMIS-10 scale among the time-to-treatment groups. - To compare 90 day clinical outcomes by the modified Rankin scale among the time-to-treatment groups - To explore the optimal timing in subgroups of age, sex, outcome category, and NOAC choice
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studyfinder@utsouthwestern.edu
Ty Shang
137563
All
Not specified
Phase 3
This study is NOT accepting healthy volunteers
NCT03021928
STU 032017-090
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Inclusion Criteria:
1. New disabling neurological deficit attributable to new ischemic stroke. 2. Minimum lesion diameter of 1.5cm on qualifying imaging. If lesion not visible on imaging, NIHSS must be greater than 4. 3. Non-valvular atrial fibrillation (paroxysmal, persistent, or permanent). 4. Not currently anticoagulated and/or will not be anticoagulated prior to starting their NOAC at the randomized time of initiation (except for DVT prophylaxis). Note: Patients who had been taking an anticoagulant prior to their qualifying index event (for any reason) are eligible for START, assuming the drug is no longer having a therapeutic effect in the patient's system by 48 hours from stroke onset. 5. Treating physician plans to anticoagulate with a FDA-approved novel oral anticoagulant (NOAC): apixaban, dabigatran, edoxaban, or rivaroxaban, or other FDA-approved NOAC. 6. Qualifying brain CT or MRI scan < 48hr from stroke onset (time last known well). If patient has been treated with thrombolytic or endovascular therapy for this stroke, then the qualifying scan is that which is performed after therapy to rule out clinically significant hemorrhagic transformation. 7. Ability to randomize within 60 hours of symptom onset.
Exclusion Criteria:
1. Any clinical or imaging evidence of spontaneous intracranial hemorrhage in the previous 6 months. Note: Patients with hemorrhagic transformation of current or previous ischemic stroke may be included per Investigator`s judgment. Sporadic microbleeds may be included per Investigator`s judgment. As a general recommendation, a cerebral microbleed is considered to be ≤ 5mm, but sometimes up to 10mm, in greatest diameter on gradient recalled echo (GRE), or T2*, MRI sequences. Any blood visualized on a CT will be classified as a macrobleed. 2. Infarct volume (estimated) is greater than 50% of middle cerebral artery territory on qualifying scan. If the full extent of the lesion is not visible, any patient with a NIHSS > 23 must be excluded. Note: The lesion does not need to be restricted to the mCA, but if the lesion volume is estimated to be greater than half of the mCA territory, the patient should be excluded. Note: In non-EVT patients, any NIHSS following the index stroke may be used to qualify the patient for START. For example, a patient that presents with a NIHSS of 10 who then receives tPA and improves to a NIHSS of 2 is still eligible for START. For patients whom had endovascular therapy, the qualifying NIHSS assessment is that which is obtained with their qualifying scan following therapy. 3. Anticipated need for major surgery over the next 30 days that would require delay, discontinuation, or extended suspension of anticoagulant of more than 5 days. 4. Symptomatic edema expected from size and location of ischemic stroke. 5. Decreased level of consciousness present or expected. 6. Life expectancy less than 90 days. 7. Follow-up in person or by telephone for 90 days is not feasible.
Other: Time-To-Treatment Randomization
Stroke, Brain and Nervous System
Stroke, Atrial Fibrillation, Anticoagulation, NOAC
Parkland Health & Hospital System
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High Intensity Exercise for Increasing Fitness in Patients With Hypertrophic Cardiomyopathy

Although current clinical guidelines stipulate that patients with hypertrophic cardiomyopathy should not partake in high intensity exercise (HIE) or competitive sport due to safety concerns, there is no clear evidence to support this notion. In fact, two exercise training interventions in this population indicates that regular moderate to vigorous intensity exercise is efficacious for improving exercise capacity and cardiorespiratory fitness, and does not increase arrhythmia burden or adverse events. Moreover, moderate intensity exercise and HIE training significantly increases cardiorespiratory fitness in patients with cardiac disease. Such improvements are associated with substantial reductions in cardiovascular mortality and might outweigh the risk of adverse events in patients with hypertrophic cardiomyopathy (HCM). Having a genetic cardiomyopathy does not grant immunity against lifestyle related cardiometabolic diseases and inactivity is rife in HCM patients likely due to misinformation/education. It is therefore paramount to further explore the benefits of regular moderate intensity exercise and HIE in patients with HCM for proper therapeutic management of the condition.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Benjamin Levine
14262
All
18 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03335332
STU 072017-048
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Inclusion Criteria:

• Male and female patients aged 18
•80 years old
• Diagnosed HCM defined by the presence of unexplained left-ventricular hypertrophy with end-diastolic wall thickness ≥ 15 mm on 2D echocardiography or wall thickness between 13 and 15 mm along with at least one other piece of evidence of hypertrophic cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family history of hypertrophic cardiomyopathy, or positive genetic test result.
Exclusion Criteria:

• A history of exercise-induced syncope or arrhythmias (ventricular tachycardia; sustained or non-sustained)
• Left ventricular outflow obstruction (≥ 50 mm Hg at rest)
• Less than 3 months post septal reduction therapy (surgery or catheter based intervention)
• Pregnancy
• Worsening clinical status or advanced heart failure (New York Heart Association class IV symptoms)
• A hypotensive responsive to exercise (an increase in exercise systolic BP throughout the exercise test of < 20mmHg compared with resting values, or an initial increase in systolic BP > 20mmHg with a subsequent fall by peak exercise of > 20mmHg, or a continuous decrease in systolic BP throughout the test of > 20mmHg, compared with baseline BP)
• Left ventricular systolic dysfunction (left ventricular ejection fraction < 55 % by echocardiography)
• Coronary artery disease as evidenced by prior myocardial infarction or angina
• Cerebrovascular disease as evidenced by prior transient ischemic attack or stroke
• A chronic orthopaedic injury which limits the ability to exercise
• Subjects unable to speak English will not be recruited because of the complex experimental studies and the need for precise communication between the volunteers and the research staff to ensure safety.
Behavioral: High intensity exercise, Behavioral: Moderate intensity exercise
Hypertrophic Cardiomyopathy
High intensity exercise, Cardiorespiratory fitness, Stroke volume reserve, Arrhythmia burden
UT Southwestern
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Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Morphine

We are examining how morphine (a commonly used pain medication) will alter responses to simulated blood loss in humans. To simulate blood loss in our research laboratory, participants will complete a test with their lower body in a custom-designed vacuum chamber for a brief period of time.
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Craig Crandall
18601
All
18 Years to 45 Years old
Phase 1/Phase 2
This study is also accepting healthy volunteers
NCT04138615
STU 092017-070
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Inclusion Criteria:

• Healthy
• Non-obese (body mass index less than 30 kg/m2)
• Body mass greater than or equal to 65 kg
Exclusion Criteria:

• Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
• Any known history of renal or hepatic insufficiency/disease
• Pregnancy or breast feeding
• Current smokers, as well as individuals who regularly smoked within the past 3 years
• Positive urine drug screen
• Currently taking pain modifying medication(s)
Drug: Morphine, Other: Placebo
Healthy
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Translating the ABCS Into HIV Care (ABCSinHIV)

The overall objective of this project is to develop and rigorously test implementation strategies to address the gap in scientific knowledge of lower use of evidence-based interventions commonly referred to as the ABCS (aspirin, blood pressure control, cholesterol control, and smoking cessation)which contributes to the growing CVD morbidity and mortality among PLH.
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studyfinder@utsouthwestern.edu
Amneris Luque
167338
All
40 Years to 79 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03902431
STU-2019-1381
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Inclusion Criteria:
Sites:
• Serve a cohort of at least 100 HIV patients
• Have an Electronic Health Record (EHR)
• Agree to collaborate on implementing feasible adaptations of intervention strategies Patients:
• Patient of the site with a diagnosis of HIV
• Age 40-79 years
• ≥5% risk for CVD as calculated using the ASCVD Risk Estimator Plus
• Willing to participate
• No plans to leave the site in the next 12 months
• Proficient in either English or Spanish
• Own a cell phone with texting capabilities Clinicians:
• Physicians, Physicians Assistants, or Nurse Practitioners who provide direct HIV care to patients
• Work at a participating site
• Willing to implement the project's intervention strategies
Exclusion Criteria:
Patients:
• Currently participating in another CVD trial
• Have experienced a prior cardiac or vascular event such as myocardial infarction (MI) or cerebrovascular accident (CVA)
• Have had a CVD procedure such as installation of a stent or angioplasty
• Have peripheral vascular disease, intermittent claudication or peripheral arterial disease
• Are pregnant
• Lacks capacity to consent Clinicians: • Planning to leave the site within the next 12 months
Behavioral: ABCS training
HIV, Cardiovascular Risk Factor, Cardiovascular
Parkland Health & Hospital System
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TARGET BP I Clinical Trial (TARGET BP I)

The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.
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Tayo Addo
20139
All
18 Years to 80 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02910414
STU-2019-0652
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Inclusion Criteria:
1. Has 3 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥150 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg when receiving 2 to 5 antihypertensive medications. 2. Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings
Exclusion Criteria:
1. Subject has renal artery anatomy abnormalities. 2. Subject has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy. 3. Subject has documented sleep apnea. 4. Subject has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association [NYHA] Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension (>60 mmHg pulmonary artery or right ventricular systolic pressure). 5. Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only). 6. Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed. 7. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.
Drug: Dehydrated alcohol, Device: Peregrine System Kit (Sham Procedure)
Hypertension
Renal Denervation, Alcohol
Parkland Health & Hospital System
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A Multi-Center Study of Riociguat in Patients With Sickle Cell Diseases

The proposed study is a Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel groups study aimed to evaluate the safety, tolerability and the efficacy of riociguat compared with placebo in patients with sickle cell disease (SCD).
Call 214-648-5005
studyfinder@utsouthwestern.edu
Alecia Nero
42280
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT02633397
STU-2019-1766
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Inclusion Criteria:

• Age ≥ 18 years
• Sickling disorder (HbSS, HbSC, HbSbeta-thalassemia, HbSD, HbSO-Arab documented by hemoglobin electrophoresis or HPLC fractionation)
• At least one of the following findings: a. Systolic blood pressure ≥ 130 mm Hg on at least two occasions at least 1 day apart (one of these may be by history), b. Macroalbuminuria as manifested by urine albumin to creatinine ratio > 300 mg/g, c. Tricuspid regurgitant velocity (TRV) > 2.9 m/sec measured by echocardiography d. NT-proBNP level ≥ 160 pg/mL e. Urinalysis protein 1 + or higher.
• Females of reproductive potential (FRP) must have a negative, pre-treatment pregnancy test. Post-menopausal women (defined as no menses for at least 1 year or post-surgical from bilateral oophorectomy) are not required to undergo a pregnancy test.
• Females of reproductive potential must agree to use reliable contraception when sexually active. Adequate contraception is defined as any combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices). Adequate contraception is required beginning at the signing of the informed consent form until one month after the last dose of riociguat.
• Patients must be willing to provide a blood sample for DNA analysis.
Exclusion Criteria:

• Pregnant or breast feeding women
• Patients with severe hepatic impairment defined as Child Pugh C
• End stage renal disease requiring dialysis
• Patients with eGFR <30 mL/min/1.73m, where GFR is estimated based on CKD-epi equation
• Patients on phosphodiesterase type 5 inhibitors (PDE-5) (such as sildenafil, tadalafil, vardenafil) and nonspecific PDE inhibitors (such as dipyridamole or theophylline) or nitrates
• Patients on strong cytochrome P450 (CYP) and P-glycoprotein 1(P-gp)/BCRP inhibitors such as systemic azole antimycotics (eg: ketoconazole, itraconazole), or HIV protease inhibitors (such as ritonavir)
• Patients on St. John's Wort
• If patients are taking antihypertensive drugs, hydroxyurea, L-glutamine, crizanlizumab, or voxelotor prior to enrollment, they are excluded until the dose level is stable for at least three months
• Systolic blood pressure <95 mm Hg at Screening Visit 1 or 2 or Week 0 before randomization
• Current enrollment in an investigational new drug trial. Patients are eligible for enrollment 30 days after the last dose of an investigational drug has been received
• Evidence of qualitative urine drug test at screening for cocaine, phencyclidine (PCP), heroin, or amphetamines within three months prior to enrollment
• Patients who have recently (last six months) experienced serious bleeding from the lung or have undergone a bronchial arterial embolization procedure.
• Pulmonary hypertension associated with Idiopathic Interstitial Pneumonias
• Medical disorder, condition, or history that in the investigator's judgment would impair the patient's ability to participate or complete this study or render the patient to be inappropriate for enrollment
Drug: Riociguat, Drug: Placebo
Sickle Cell Disease, Cardiovascular
SCD, Sickle Cell Disease, Riociguat, Adempas
Parkland Health & Hospital System
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A Study of AKCEA-APOCIII-LRx Administered to Patients With Familial Chylomicronemia Syndrome (FCS) (BALANCE)

The purpose of the study is to evaluate the efficacy of AKCEA-APOCIII-LRx as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.
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Zahid Ahmad
69829
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04568434
STU-2020-1143
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Key
Inclusion Criteria:

• A diagnosis of genetically confirmed Familial Chylomicronemia Syndrome (type 1 Hyperlipoproteinemia)
• Fasting TG ≥ 880 mg/dL (10 millimoles per liter (mmol/L)) at Screening
• History of pancreatitis
• Stable doses of statins, omega-3 fatty acids, fibrates, or other lipid-lowering medications are allowed Key
Exclusion Criteria:

• Acute coronary syndrome within 6 months of Screening
• Major surgery within 3 months of Screening
• Have any other conditions, which, in the opinion of the Investigator would make the participant unsuitable for inclusion, or could interfere with participating in or completing the study
Drug: AKCEA-APOCIII-LRx, Drug: Placebo
Cardiovascular, Familial Chylomicronemia Syndrome
FCS
UT Southwestern
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Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients

Lipodystrophies are rare disorders characterized by selective loss of adipose tissue and predisposition to insulin resistance and its metabolic complications. Hepatic steatosis is a common complication in patients with partial and generalized lipodystrophies.Despite aggressive management of diabetes and hyperlipidemia, hepatic steatosis and its complications present a therapeutic challenge in many patients. Due to this large disease burden, it is important to assess the efficacy and safety of novel therapies for hepatic steatosis in patients with lipodystrophies.There are, however, no systematic studies evaluating various therapeutic interventions for reducing hepatic steatosis in patients with lipodystrophies. A variety of drugs have been investigated in nonlipodystrophic patients with non-alcoholic hepatic steatosis and steatohepatitis (NASH) or non-alcoholic fatty liver disease (NAFLD). Recent data support the activation of the farnesoid X receptor (FXR, NR1H4), a nuclear hormone receptor regulated by bile acids, for treatment of NASH and NAFLD. FXR activates transcription of several genes particularly the atypical nuclear receptor small heterodimer partner (SHP, NR0B2) and thus can influence triglyceride metabolism within hepatocytes.Both cholic acid (CA) and chenodeoxycholic acid (CDCA) are ligands for FXR, however, UDCA which is the 7 hydroxy β-epimer of CDCA, does not activate FXR. Obeticholic acid (OCA) is a first-in-class selective FXR agonist which has approximately 100 fold greater FXR-agonistic activity in the nanomolar range, as compared to CDCA .It therefore appears that FXR modulation offers interesting therapeutic possibilities in treating hepatic steatosis. This study is primarily designed to study efficacy of OCA, a strong FXR ligand, in reducing hepatic triglyceride levels in patients with hepatic steatosis and Familial Partial Lipodystrophy (FPLD). If proven to be effective, it may reduce morbidity and mortality as a result of sequelae of hepatic steatosis in patients with lipodystrophies.
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Abhimanyu Garg
12461
All
18 Years to 70 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02430077
STU 062014-033
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Inclusion Criteria:
1. Patients with familial partial lipodystrophy of the Dunnigan variety with heterozygous disease-causing missense mutation in lamin A/C (LMNA) gene. 2. Hepatic steatosis (>5.6% hepatic triglyceride content) as demonstrated by 1H magnetic resonance spectroscopy. 3. Age 18-70 years. 4. Alcohol intake of less than 20 g per day in females and 30 g per day in males. 5. Participants and their partners with whom they are having sex, must use medically-acceptable birth control (contraceptives) during the study. Medically-acceptable methods of contraception include: (1) surgical sterilization, such as hysterectomy, tubal ligation or vasectomy. (2) approved hormonal contraceptives, such as birth control pills, patch or ring; Depo-Provera, Implanon. (3) barrier methods, such as condom, cervical cap or diaphragm used with a spermicide. (4) an intrauterine device (IUD).
Exclusion Criteria:
1. Laboratory or other histologic findings highly suggestive of liver disease due to causes other than non-alcoholic steatohepatitis, such as chronic viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, biliary obstruction or genetic liver diseases such as Wilson's disease, hemochromatosis or alpha-1-antitrypsin deficiency. 2. Treatment with drugs associated with steatohepatitis, e.g., corticosteroids, high dose estrogens, methotrexate, amiodarone, tamoxifen, valproic acid, sulfasalazine, or oxacillin for more than 2 weeks in the 6 months prior to the study. 3. Decompensated liver disease as evidenced by clinical features of hepatic failure (variceal bleeding, ascites, hepatic encephalopathy etc.) and laboratory investigations (prolonged prothrombin time with INR > 1.3, hypoalbuminemia with serum albumin less than 3.0 g/dL, direct bilirubin > 1.3 mg/dL, or presence of esophageal varices etc.) 4. Evidence of hepatocellular carcinoma: alpha-fetoprotein levels greater than 200 ng/ml and/or liver mass on imaging study suggestive of liver cancer. 5. Use of drugs which can potentially decrease hepatic steatosis during previous 3 months; ursodeoxycholic acid, thiazolidinediones, high-dose vitamin E, betaine, acetylcysteine and choline. 6. Significant systemic or major illnesses other than liver disease, such as congestive heart failure, cerebrovascular disease, respiratory failure, renal failure (serum creatinine >2 mg/dL), acute pancreatitis, organ transplantation, serious psychiatric disease, and malignancy, that could interfere with the trial and adequate follow up. 7. Acute medical illnesses precluding participation in the studies. 8. Known HIV-infected patient. 9. Current substance abuse. 10. Pregnant or lactating woman. 11. Hematocrit of less than 30%. 12. History of weight loss during past 3 months. 13. Patients on bile acid binding resins, cholestyramine, colestipol or colesevelam. 14. Hypersensitivity or intolerance to OCA or any components of its formulation. 15. Failure to give informed consent 16 .Previous clinical diagnosis of diabetes mellitus or fasting blood glucose ≥ 126 mg/dL or hemoglobin A1c ≥ 6.5%.
Drug: Obeticholic Acid, Drug: Placebo
Familial Partial Lipodystrophy, Liver
Hepatic Steatosis
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Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities (ASPIRE)

The purpose of this study is to evaluate whether clopidogrel 75 mg daily on a background of aspirin 75-100 mg/d for clinically indicated duration or for an additional 12 months will lead to an increased rate of primary patency, limb salvage, non-fatal myocardial infarction (MI), ischemic stroke, and survival, in patients receiving endovascular treatment of PAD at end of study treatment.
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Subhash Banerjee
73842
All
18 Years to 90 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02217501
STU 122013-065
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Inclusion Criteria:
General:
• Signed informed consent
• At least 18 years old
• Documented symptomatic iliac, femoropopliteal (FP) or below-the knee artery (BTK) atherosclerotic disease (Rutherford/Becker category 2, 3 or ≥4)
• Undergone clinically indicated uncomplicated endovascular intervention to one or more locations of the iliac, femoropopliteal below-the knee arteries
• Estimated survival ≥1 year in the judgment of the primary operator
• Pre-index procedure use of ASA, clopidogrel or both at any dose Angiographic:
• De novo or restenotic lesions in the common and/or external iliac artery, superficial femoral artery (SFA), popliteal artery, tibio-peroneal (TP) trunk, anterior tibial (AT) artery, peroneal artery (PA) or posterior tibial (PT) artery (applies to all target lesions if multiple)
• Subjects with multiple planned procedures can be enrolled after the completion of the last planned procedure.
Exclusion Criteria:
General:
• Complicated qualifying procedure (perforation, flow limiting dissection, distal embolization requiring re-intervention, need for repeat endovascular, surgical revascularization, amputation or blood transfusion prior to hospital discharge following an index procedure
• Extended hospital stay >7 days following the index procedure
• Allergy to aspirin or clopidogrel
• Life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial
• Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
• Intolerance to antiplatelet, anticoagulant, or thrombolytic medications
• Platelet count <90,000 mm3 or >600,000 mm3
• Serum creatinine >2.5 mg/dL
• Dialysis-dependent end stage renal disease
• Pregnancy
• Current participation in another drug or device trial that requires interruption of dual-antiplatelet therapy with aspirin or clopidogrel for the duration of the study
• Planned surgeries, endovascular or other non-vascular or cardiac procedures
• Concurrent warfarin or other chronic oral anticoagulant therapy
• Contraindication(s) to the use of AT (history of intra-cerebral bleed, presence of intra-cerebral mass, recent or <6 weeks gastrointestinal bleed, blood transfusion within the last 6 weeks, any trauma requiring surgery or blood transfusion within the last 4 weeks or any surgical procedure within the last 4 weeks. Angiographic:
• Endovascular intervention to iliac, femoropopliteal or BTK artery bypass graft
• Persistent, intraluminal thrombus of the proposed target lesion at the completion of the index procedure
• Perforated vessel as evidenced by extravasation of contrast media
• Vascular graft, aneurysm or postsurgical stenosis of the target vessel
Drug: Clopidogrel, Drug: Acetylsalicylic acid (ASA)
Peripheral Arterial Disease, Cardiovascular
peripheral arterial disease, antiplatelet therapy
Parkland Health & Hospital System
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Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex AAAs Using Fenestrated- Branched Devices

The purpose of this study is to assess the clinical outcomes and radiation of the use of off-the-shelf and custom-made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms in patients having appropriate anatomy. The study consists of three cohorts. The first 2 cohorts are the continuation of the current IDE study. The first cohort is aimed to assess the use of custom-made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms in standard and high-risk patients having appropriate anatomy (Fenestrated-CMD cohort). The second cohort (Type I-III thoracoabdominal cohort) includes standard and high-risk patients with type I- III thoracoabdominal aneurysms that require the use of branched/fenestrated CMDs, or, in selected cases, the Zenith Thoracoabdominal Branch (Zenith® t-Branch™) device. Finally, the third cohort (the Arch cohort) will include 10 high-risk patients with aortic arch aneurysms treated by patient-specific stent-grafts with one to three inner branches or a scallop.
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Carlos Timaran
68421
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02266719
STU 072014-015
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General Inclusion Criteria A patient is deemed suitable for inclusion in the study if the patient has at least one the following: 1. Juxtarenal or suprarenal AAA, type I-IV thoracoabdominal aortic aneurysms or aortic arch aneurysms or dissections with diameter ≥5.0 cm in diameter or 2 times the normal aortic diameter; 2. Aneurysm with history of growth ≥0.5 cm/year; 3. Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation. 4. Patients that are not eligible for treatment with commercially available endografts. 5. Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria. General Exclusion Criteria A patient must be excluded from the clinical investigation if any of the following are true: 1. Age <18 years; 2. Life expectancy <2 years; 3. Pregnant, breast-feeding, or planning on becoming pregnant within 60 months; 4. Inability or refusal to give informed consent by the patient or a legally authorized representative; 5. Unwilling or unable to comply with the follow-up schedule; 6. Prior surgical or interventional procedure within 30 days of the anticipated date of the fenestrated procedure, with the exception of planned staged procedures to provide access for repair (e.g. staged iliac conduit, thoracic endovascular aortic aneurysm repair for proximal aneurysms, elephant trunk repair), to facilitate the procedure by allowing open reparation of a target artery not amenable to revascularization with the investigational device, such us an internal iliac artery, subclavian artery or visceral artery with early bifurcation, tortuosity or occlusive disease preventing successful placement and alignment side stents, or to treat proximal aortic aneurysms. 7. Participation in another clinical or device trial, with the exception of observational studies, participation in another investigational endovascular endograft protocol, percutaneous aortic valve protocol, or concomitant clinical trials designed to evaluate medical therapy strategies to reduce perioperative risk during fenestrated-branched endovascular repair, including risks of renal dysfunction, contrast-induced nephropathy, neurologic, spinal cord or cardiac complications, and/or use of advanced imaging to reduce radiation exposure during implantation of these devices. Participation in investigational device trials not encompassed by the IDE protocol should be performed remotely from the fenestrated/branched repair (>30 days). Participation in medical therapy trial or advanced imaging trial designed to improve peri-operative outcomes or to reduce radiation exposure of fenestrated/branched endografts may be concurrent with the IDE study. Examples include therapy directed to reduce rates of spinal cord injury, stroke and contrast-induced nephropathy associated with implantation of fenestrated-branched stent-grafts or advanced imaging trials designed to reduce radiation exposure during repair. 8. Patients with ruptured aortic aneurysm requiring urgent or emergent repair, with the exception of patients with contained, stable ruptures with anatomy suitable for an off-the-shelf design. 9. Patients who meet anatomical criteria for commercially available aortic stent-grafts according to proposed instructions for use of these devices. Medical Exclusion Criteria Patients must be excluded from the study if any of the following conditions are true: 1. Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold 2. History of anaphylactic reaction to contrast material that cannot be adequately pre-medicated 3. Leaking or ruptured aneurysm associated with hypotension 4. Uncorrectable coagulopathy 5. Mycotic aneurysm or patients with evidence of active systemic infection. 6. History of connective tissue disorder (e.g. vascular Ehlers Danlos, Marfan syndrome), with the exception of those patients who had prior open surgical aortic replacement or endovascular repair, where a surgical graft or an endograft would serve as landing zone for the investigational endograft, those who are deemed prohibitive risk for open repair or connective tissue disorders with no vascular effects (e.g. non-vascular types of Ehlers Danlos). 7. Body habitus that would inhibit x-ray visualization of the aorta and its branches. Anatomical Exclusion Criteria Patient must be excluded from the study if any of the following is true: 1. Inadequate femoral or iliac access compatible with the requirements of the required delivery system. 2. Inability to perform a temporary or permanent open surgical or endovascular iliac conduit for patients with inadequate femoral/iliac access. 3. Absence of a landing aortic segment in the distal thoracic aorta above the diaphragmatic hiatus with: 1. A diameter measured outer to the outer wall greater than 42 mm or less than 19 mm; 2. Parallel aortic wall with >20% diameter change and with significant calcification and/or thrombus in the selected area of the seal zone. 4. Visceral anatomy not compatible with the investigational device due to excessive occlusive disease or small size not amenable to stent graft placement. 5. Unsuitable distal iliac arterial fixation site and anatomy: 1. Common iliac artery fixation site diameter measured outer wall to outer wall on a section image (CT)< 8.0 mm with inability to perform surgical conduit. 2. Iliac artery diameter measured outer wall to outer wall on a sectional image (CT) > 21 mm at distal fixation site, with inability to perform open internal iliac artery revascularization or iliac branch stent graft or custom iliac extension with fenestration. 3. Iliac artery distal fixation site <10 mm in length. 4. Inability to preserve at least one hypogastric artery. For patients in the type I-III TAAA cohort, the intended use criteria are the same for both the fenestrated/branched CMD vs the off-the-shelf device. The CMD will preferably be used, unless an urgent repair is indicated or the waiting period for design or manufacturing of the CMD is considered unacceptable. Additional anatomical inclusion criteria for aortic arch devices 1. Proximal aortic fixation zone: 1. Native aorta or surgical graft 2. Diameter: 20-42mm 3. Proximal neck length ≥ 20mm 4. Ascending aortic length ≥50mm 5. Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion 2. Distal aortic fixation zone: 1. Native aorta or surgical graft 2. Diameter: 20-42mm 3. Distal neck length ≥20mm 4. Distal fixation will be obtained with stent-grafts in a staged repair 3. Supra-aortic trunk (brachiocephalic) vessels 1. The arch branch device will typically have two or three branches with additional modifications to the design that allows for a single branch or combination of branch and scallop if a customized version is required. An extra-anatomic bypass graft may be done in conjunction (or in a staged fashion) with the procedure, as required. For the two-branch design, the vessels most commonly incorporated will be the innominate artery and left common carotid artery. However, the innominate artery may be coupled with the left subclavian artery in the setting of a bovine arch whereby the flow to the left carotid would come from a left subclavian to carotid bypass. Similarly, the left carotid and subclavian artery may be branched, or simply one vessel branched should specific anatomic limitations exist. In such a situation, multiple extra-anatomic bypasses may be necessary. A design with a single subclavian retrograde branch and scallop to the left carotid artery may be used to extent the landing zone to Zone 1. Finally, a design with two antegrade inner branches for the innominate and left common carotid, and one retrograde inner branch for the left subclavian artery may be used in select cases. Thus, the inclusion criteria are defined for each artery, yet any combination of arteries may be used for a repair. i. Innominate artery 1. Native vessel or surgical graft 2. Diameter: 8-22mm 3. Length of sealing zone ≥10mm 4. Acceptable tortuosity ii. Left (or right) common carotid artery 1. Native vessel or surgical graft 2. Diameter 6-16mm 3. Length of sealing zone ≥10mm 4. Acceptable tortuosity iii. Left (or right) subclavian artery 1. Native vessel or surgical graft 2. Diameter: 5-20mm 3. Length of sealing zone ≥10mm 4. Acceptable tortuosity 4. In the setting of an aortic dissection the following criteria must exist: a. Access into the true lumen from the groin and at least one supra-aortic trunk vessel b. A sealing zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stent-graft would be anticipated to seal off the dissection lumen c. A sealing zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen, or surgically created d. A true lumen size large enough to deploy the device and still gain access into the target branches 5. In the setting of more distal disease, the repair may be coupled with a thoracoabdominal branched device, infrarenal device, and/or internal iliac branch device. 6. Iliac anatomy must allow for the delivery of the arch branch device which is loaded within a 20F-24F sheath. Conduits to the iliac vessels or aorta may be used if deemed necessary.
Device: Fenestrated CMD, Device: Type I - III TAAA, Device: Arch cohort
Aortic Aneurysm, Abdominal, Cardiovascular, Thoracic Aneurysm
Aortic Aneurysm, Abdominal [C14.907.055.239.075], Thoracic Aneurysm
UT Southwestern
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Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration (IBPS)

This study is an open label randomized clinical trial that comparing intradialytic blood pressure slope-based ultrafiltration prescriptions to standard care in the chronic fluid management of maintenance hemodialysis patients. It also includes a cross sectional component evaluating the associations between intradialytic blood pressure slopes ascertained over 2 week periods with measurements of extracellular water/body weight obtained with multifrequency bioimpedance spectroscopy.
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Peter Van Buren
76950
All
18 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03303391
STU 032017-024
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Inclusion Criteria:

• Age greater than 18 years
• End Stage Renal Disease on Maintenance Hemodialysis
• Hypertension defined as systolic blood pressure > 140 mmHg pre-dialysis or >130 mmHg post dialysis
Exclusion Criteria:

• Hemodialysis Vintage < 1 month
• Pregnancy
• Nadir Systolic Blood Pressure < 95 mmHg
• Pre or Post dialysis systolic blood pressure > 180 mmHg
• Decrease in systolic blood pressure >60 mmHg from pre to post dialysis
• Ultrafiltration rate >13 mL/kg/hr
• Peridialytic Midodrine Use
• Intradialytic Clonidine use
• Documented Antihypertensive Medication Non-adherence Bioimpedance will not be peformed on patients with
• amputated arms or legs
• cardiac defibrillator or pacemaker
• presence of metal prostheses
Other: Intradialytic Blood Pressure Slope Based Ultrafiltration
Hypertension, ESRD, Extracellular Fluid Alteration, Kidney
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AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke (ARCADIA)

Objectives - Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. - Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.
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Ty Shang
137563
All
45 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03192215
STU 112017-065
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Inclusion Criteria:

• Age ≥ 45 years.
• Clinical diagnosis of ischemic stroke + brain imaging to rule out hemorrhagic stroke.
• Modified Rankin Scale (MRS) score ≤ 4.
• Ability to be randomized within 3 to 180 days after stroke onset.
• ESUS, defined as all of the following:
• Stroke detected by CT or MRI that is not lacunar. Lacunar is defined as a subcortical (this includes pons and midbrain) infarct in the distribution of the small, penetrating cerebral arteries whose largest dimension is ≤1.5 cm on CT or ≤2.0 cm on MRI diffusion images/<1.5 cm on T2 weighted MR images. The following are not considered lacunes: multiple simultaneous small deep infarcts, lateral medullary infarcts, and cerebellar infarcts. Patients with a clinical lacunar stroke syndrome and no infarct on imaging are excluded.
• Absence of extracranial or intracranial atherosclerosis causing ≥50 percent luminal stenosis of the artery supplying the area of ischemia. Patients must undergo vascular imaging of the extracranial and intracranial vessels using either catheter angiography, CT angiogram (CTA), MR angiogram (MRA), or ultrasound, as considered appropriate by the treating physician and local principal investigator.
• No major-risk cardioembolic source of embolism, including intracardiac thrombus, mechanical prosthetic cardiac valve, atrial myxoma or other cardiac tumors, moderate or severe mitral stenosis, myocardial infarction within the last 4 weeks, left ventricular ejection fraction <30 percent, valvular vegetations, or infective endocarditis). Patent foramen ovale is not an exclusion. All patients must undergo electrocardiogram, transthoracic or transesophageal echocardiography (TTE or TEE) and at least 24 hours of cardiac rhythm monitoring (Holter monitor or telemetry or equivalent). Additional cardiac imaging, such as cardiac MRI, or cardiac CT will be performed at the discretion of the local treating physician and principal investigator. Additional cardiac rhythm monitoring, such as monitored cardiac outpatient telemetry (MCOT) or an implanted cardiac monitor, will be at the discretion of the treating physician and local principal investigator.
• No other specific cause of stroke identified, such as arteritis, dissection, migraine, vasospasm, drug abuse, or hypercoagulability. Special testing, such as toxicological screens, serological testing for syphilis, and tests for hypercoagulability, will be performed at the discretion of the treating physician and local principal investigator.
Exclusion Criteria:

• History of atrial fibrillation (AF), AF on 12-lead ECG, or any AF of any duration during heart-rhythm monitoring prior to randomization.
• Clear indication for treatment-dose anticoagulant therapy, such as venous thromboembolism or a mechanical heart valve.
• Need for antiplatelet agent, such as aspirin or clopidogrel
• History of spontaneous intracranial hemorrhage.
• Chronic kidney disease with serum creatinine ≥2.5 mg/dL.For Canadian sites only, estimated creatinine clearance (eCrCl) <15 mL/min is also an exclusion criterion.
• Active hepatitis or hepatic insufficiency with Child-Pugh score B or C.
• Clinically significant bleeding diathesis.
• Unresolved anemia (hemoglobin <9 g/dL) or thrombocytopenia (<100 x 10E9/L).
• Clinically significant gastrointestinal bleeding within the past year (e.g., not due to external hemorrhoids).
• At risk for pregnancy: premenopausal or postmenopausal woman within 12 months of last menses without a negative pregnancy test or not committing to adequate birth control, which includes an oral contraceptive, two methods of barrier birth control such as condom with or without spermicidal lubricant + diaphragm, or abstinence.
• Known allergy or intolerance to aspirin or apixaban.
• Concomitant participation in another clinical trial involving a drug or acute stroke intervention.
• Considered by the investigator to have a condition that precludes follow-up or safe participation in the trial.
• Inability of either participant or surrogate to provide written, informed consent for trial participation.
Drug: Apixaban, Drug: Aspirin
Stroke, Brain and Nervous System
Atrial Cardiopathy, Cryptogenic stroke, Ischemic stroke, Apixaban, Aspirin
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A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.
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Sonja Bartolome
115047
All
18 Years to 75 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03683186
STU-2018-0148
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Inclusion Criteria:
1. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study. 4. Both male and female subjects agree to use a medically acceptable method of contraception throughout the entire study period from informed consent through the 30 day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (i.e., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of ralinepag.
Exclusion Criteria:
1. Subjects who prematurely discontinued investigational medicinal product (IMP) due to a drug-related AE/SAE or tolerability issue in the preceding ralinepag study in which they were enrolled, or subjects who did not complete all protocol defined study procedures at a Study Drug Termination Visit or End of Study Visit in the preceding ralinepag study. 2. Subjects who withdrew consent during participation in another ralinepag study. 3. Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit), or are lactating or breastfeeding. 4. Subjects who have undergone lung or heart/lung transplant or the initiation of long-term parenteral or inhaled therapy with a prostacyclin during the time since participation in their original ralinepag study. 5. Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study.
Drug: Ralinepag
Pulmonary Hypertension, Pulmonary Arterial Hypertension, Hypertension, Cardiovascular Diseases, Hypertension, Pulmonary, PAH, Connective Tissue Diseases, Familial Primary Pulmonary Hypertension, Vascular Diseases, Lung Diseases, Respiratory Tract Disease
Prostacyclin, Connective Tissue Disease-Associated, 6 Minute Walk Test, 6 Minute Walk Distance, Pulmonary Vascular Resistance, Right Ventricular Function
UT Southwestern
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Mechanisms of Exercise Intolerance in Heart Failure With Preserved Ejection Fraction

The global objective of this study is to determine the mechanisms of exercise intolerance and dyspnea on exertion (DOE) in patients with HFpEF and based on this pathophysiology, test whether specific exercise training programs (whole body vs single leg) will result in improved exercise tolerance.
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Benjamin Levine
14262
All
60 Years to 90 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04068844
STU-2019-0617
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Inclusion Criteria:

• signs and symptoms of heart failure
• an ejection fraction > 0.50
• objective evidence of diastolic dysfunction
Exclusion Criteria:

• age < 60 years
• BMI > 50 kg/m2
• PDE5 inhibitor use
• Severe valvular disease
• Severe COPD
• CKD 4 or higher
• Contra-indication to MRI.
Behavioral: Exercise training
Heart Failure, Diastolic
Exercise, Hemodynamics,, Heart failure
UT Southwestern
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A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (PH) (CIPHER)

The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood samples associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH; to estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures in identifying participants with PH by comparing the biomarker signatures to right heart catheterization (RHC) and to compare the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures with the sensitivity, specificity, positive predictive value, and negative predictive value of transthoracic echocardiogram (TTE) in identifying participants with PH documented by RHC.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Elizabeth Hardin
83556
All
18 Years and over
Early Phase 1
This study is NOT accepting healthy volunteers
NCT04193046
STU-2020-0561
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Inclusion Criteria:

• Having undergone an right heart catheterization (RHC) within 18 months (prevalent PH participants) or 6 months (prevalent non-PH participants) or have undergone or planned RHC within 6 weeks (incident participants). The results of the incident RHC (incident participants) or the most recent RHC (prevalent participants) will be used to classify the participant in one of the above study population categories
• Medically stable on the basis of physical examination, medical history and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
• Must provide an Informed Consent Form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
• Must provide a separate informed consent (or their legally-acceptable representative must sign) if he or she agrees to provide an optional (deoxyribonucleic acid [DNA]) sample for research (where local regulations permit). Refusal to give consent for the optional (DNA) research sample does not exclude a participant from participation in the study
Exclusion Criteria:

• Participants requiring renal dialysis
• History of lung or heart transplant (waiting list status or consideration of enlisting is allowed)
• Severe left ventricular dysfunction: Left ventricular ejection function less then (<) 35 percent (%)
Other: Blood Sample
Hypertension, Pulmonary, Cardiovascular, Lung/Thoracic
UT Southwestern
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CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of AKCEA-TTR-LRx in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

To evaluate the efficacy of AKCEA-TTR-LRx compared to placebo for 120 weeks in patients with ATTR-CM receiving available standard of care (SoC). For more information, please visit https://www.cardio-ttransform.com/.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Justin Grodin
74652
All
18 Years to 90 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04136171
STU-2019-1609
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Inclusion Criteria:

• Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal or abstinent. If engaged in sexual relations of child-bearing potential, agree to use 1 highly effective contraceptive method
• Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the participant or the participant's non-pregnant female partner must be using a highly effective contraceptive method
• Amyloid deposits in cardiac or non-cardiac tissue confirmed by Congo Red (or equivalent) staining OR technetium scintigraphy (99mTc -3,3-diphosphono-1,2- propanodicarboxylic acid [DPD-Tc], 99m Tc-pyrophosphate [PYP-Tc], or 99m Tc-hydroxymethylene-diphosphonate [HMDP-Tc]) with Grade 2 or 3 cardiac uptake in the absence of abnormal light chains ratio, centrally confirmed
• End-diastolic interventricular septum thickness of > 12 mm on Screening echocardiogram
• New York Heart Association (NYHA) class I-III
Exclusion Criteria:

• Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening
• Cardiomyopathy not primarily caused by ATTR-CM, for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease
• Monoclonal gammopathy of undetermined significance (MGUS) and/or immunoglobulin free light chain ratio < 0.26 and > 1.65, unless fat, bone marrow, or heart biopsy confirming the absence of light chain by mass spectrometry or immunoelectron microscopy
• Prior liver or heart transplant, and/or Left Ventricular Assist Device (LVAD) or anticipated liver transplant or LVAD within 1 year after randomization
• Current or previous treatment with Tegsedi™ (inotersen) or Onpattro™ (patisiran) or other oligonucleotide or RNA therapeutic (including siRNA)
• Current treatment with diflunisal, doxycycline, and/or calcium-channel blocker. Participants receiving any of these agents must respect a wash-out period of 14 days before randomization.
Drug: AKCEA-TTR-LRx, Drug: Placebo
Cardiovascular, Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
TTR, Amyloidosis, Cardiomyopathy
UT Southwestern
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Xeltis Bioabsorbable Pulmonary Valved Conduit Early Feasibility Study (Xplore2)

This is a multi-center prospective, single-arm, non-randomized, open label study to assess feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Robert Jaquiss
171960
All
2 Years to 21 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03022708
STU-2020-1196
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Inclusion Criteria:
1. Patient requiring RVOT reconstruction, suitable for 16 mm or 18 mm valved conduit. 2. Male or Female. 3. Age > 2 years and < 22 years. 4. Right Ventricular to Pulmonary Artery peak gradient > 35mm Hg or moderate or severe Pulmonary regurgitation (≥3+), or have both (except for the patients undergoing a Ross procedure) 5. The patient, and the patient's parent / legal representative where appropriate, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent by signing the approved informed consent form. 6. The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.
Exclusion Criteria:
1. Need for or presence of prosthetic heart valve at other position. 2. Need for concomitant surgical procedures (non-cardiac). 3. Patients with previously implanted pacemaker (including defibrillators), or mechanical valves. 4. Active infection or requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics) or viral infection. 5. Active endocarditis. 6. Leukopenia, defined as White Blood cell Count < than:
• 2-12 years: 5.0 ×103 /μL
• 12 years
•Adult:
• Male: 4.5×103 /μL
• Female: 4.5 ×103 /μL 7. Acute or chronic anemia, defined as Hemoglobin < than:
• 2-12 years 11.5 g /dl
• 12-18:
• Male: 13 g /dl
• Female 12 g /dl
• Adult:
• Male: 13.5 g /dl
• Female: 12 g /dl Patients can be transfused to meet eligibility criteria 8. Thrombocytopenia, defined as Platelet count < than:
• 150,000/mm3 Patients can be transfused to meet eligibility criteria 9. Severe chest wall deformity, which would preclude placement of the PV conduit. 10. Pulmonary hypertension (≥ half of systemic systolic pressure) 11. Right ventricular outflow tract aneurysm. 12. Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials. . 13. Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs. 14. Subject has chronic inflammatory / autoimmune disease. 15. Need for emergency cardiac or vascular surgery or intervention. 16. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year. 17. Currently participating, or participated within the last 30 days, in an investigational drug or device study. 18. Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse
•this includes the illicit use of cannabis within the last 12 months. 19. Pregnancy. 20. Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years 21. Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance.
Device: Xeltis Bioabsorbable Pulmonary Valved Conduit
Heart Defect, Congenital
Children’s Health
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Polypill Strategy for Heart Failure With Reduced Ejection Fraction

Heart failure with a reduced ejection fraction (HFrEF) represents a significant public health burden in the United States, with a growing prevalence particularly among African Americans and Hispanic Americans and individuals of low socioeconomic status (SES). Although effective therapies exist, gaps in their uptake contribute substantially to the excess burden of heart failure. The "polypill" is an inexpensive once daily pill containing three agents proven to improve morbidity and mortality in heart failure and represents potential strategy for increasing the utilization of proven HF therapies. The proposed study is a pragmatic, single-center, randomized trial to test the feasibility and effectiveness of a polypill-based strategy for the treatment of HFrEF in a low-income, racially diverse population.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Ambarish Pandey
125045
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04633005
STU-2020-1340
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Inclusion Criteria:

• Adults age > = 18 years
• Newly diagnosed HF with left ventricular ejection fraction <= 40%
• New York Heart Association class II, III, or IV symptoms
Exclusion Criteria:

• Age < 18
• Systolic blood pressure < 120 mm Hg at enrollment
• Estimated glomerular filtration rate < 30 mL/min/1.73 m2 as measured by the simplified
• MDRD formula
• Serum potassium > 5.0 mEq/L
• Current need for inotropes
• Cardiac index < 2.2 L/min/m2
• History of revascularization within 30 days or plan for revascularization
• History of type 1 diabetes mellitus
• History of allergic reaction or intolerance to a beta-blocker (BB), mineralocorticoid receptor antagonist (MRA), or sodium glucose cotransporter 2 inhibitor (SGLT2i)
• Contraindication to receive any of the components of the polypill
• Pregnancy
• Comorbidities that might be expected to limit lifespan within the 6-month study period
• Inability to provide written informed consent
Drug: Polypill, Drug: Control Rx
Heart Failure, Heart
Parkland Health & Hospital System
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A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease (COORDINATE)

COORDINATE-Diabetes is a cluster-randomized clinical trial to test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with type 2 diabetes mellitus and cardiovascular disease.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Ambarish Pandey
125045
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03936660
STU-2020-0323
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Inclusion Criteria:

• Age ≥ 18 years old
• Diagnosis of Type 2 diabetes mellitus (T2DM)
• History of at least one of the following conditions: 1. Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA) 2. Stroke and/or carotid artery stenosis (≥50%) 3. Peripheral Arterial disease (defined as claudication with ABI<0.9, prior peripheral revascularization, and/or amputation due to circulatory insufficiency)
• Ability to communicate with site staff and understand and provide written informed consent and proof of Health Insurance Portability and Accountability Act (HIPAA) authorization
Exclusion Criteria:

• Determined to be highly unlikely to survive and/or to continue follow-up in that clinic for at least 1 year, as identified by site investigator
• GFR<30 mL/min/1.73m2
• Already on all guideline-recommended therapies for T2DM and CVD
• Absolute contraindication to any of the guideline recommended therapies for T2DM and CVD
Other: Intense Education Intervention
Diabetes Mellitus, Type 2, Cardiovascular Diseases
COORDINATE-DIABETES, COORDINATE, T2DM, Diabetes Mellitus, Type 2, Cardiovascular Disease, Prevention
Parkland Health & Hospital System
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Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)

Call 214-648-5005
studyfinder@utsouthwestern.edu
Justin Grodin
74652
All
18 Years to 80 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT04210375
STU-2021-0088
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Inclusion Criteria:
1. Adults 18 and 80 years with stable NYHA Class II or III HF diagnosis (ischemic or non-ischemic confirmed by medical history) at least 6 months prior to enrollment as confirmed by medical history. 2. Stable HF defined as no hospitalizations for cardiac-related issues within the previous 3 months prior to the screening visit or between screening and randomization, other than for routine device generator changes. 3. Subjects with clearly interpretable echocardiographic images and with a screening LVEF ≤ 40% in the absence of ≥ Grade 3 valvular disease on 2D-TTE. 4. Subjects must be taking clinician-directed appropriate pharmacological therapy for HF as per the 2017 ACC/AHA/HFSA treatment guidelines at stable doses (except for diuretics) for at least 3 months prior to screening. Subjects with implantable cardioverter-defibrillators (ICDs), if the devices are not "pacing", are eligible. 5. Body mass index ≥18 kg/m2 and ≤40 kg/m2. 6. Screening hemoglobin ≥9.0 g/dL, platelets ≥100 K/mL, ANC ≥1500/mL. 7. Able and willing to use adequate contraception until the end of the study. 8. Capable of providing informed consent and to comply with the protocol.
Exclusion Criteria:
1. Participating in any other study, have received any other investigational drug within 30 days prior to screening or 5-half-lives or any other investigational implanted device within 30 days prior to screening, or are taking part in a nonmedication study which, in the opinion of the Investigator, would interfere with study compliance or outcome assessments. 2. Any past participation in a study that has investigated the NRG-1 pathway (e.g., Neucardin, Cimaglermin). 3. Heart failure due to hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic right ventricula dysplasia (ARVD), stress-induced ("Takotsubo") cardiomyopathy, chemotherapy-induced cardiomyopathy, peripartum cardiomyopathy, infiltrative or inflammatory cardiomyopathies, and primary valvular disease. 4. Acute coronary syndrome within 3 months of screening or acute MI within 6 months of screening. 5. Cardiac surgery, coronary artery revascularization, percutaneous coronary intervention, or valvuloplasty within 3 months prior to screening. 6. Any subject who has received an indication for coronary revascularization within 3 months prior to screening. 7. Any major surgical procedure within 1 month prior to screening or planned surgical procedure during the study period. 8. Sustained systolic blood pressure <100 mm Hg and/or diastolic blood pressure <50 mm Hg. 9. Sustained resting heart rate >100 beats per minute. 10. Cerebrovascular accident or hospitalizations for CV (cardiovascular) causes other than routine device generator changes, including HF, chest pain, stroke, transient ischemic attack, or arrhythmias within 3 months prior to randomization. 11. At screening have an abnormal or clinically significant 12-lead ECG abnormality, ei.; (QRS >120 msec, PR >210 msec, heart rate (HR) <45 bpm, sustained HR >100 bpm) that, in the opinion of the Investigator, would affect efficacy or safety evaluation or place the subject at risk. 12. History or evidence of clinically significant arrhythmia uncontrolled by drug therapy or use of an implantable defibrillator, long QT syndrome, or evidence of QT prolongation with QTcF >450 ms for males or QTcF >470 ms for females prior to randomization. 13. Clinically significant renal dysfunction as measured by the estimated GFR <45 mL/min/1.73m2 at screening, or a clinically significant change in renal function between screening and baseline. 14. Clinically significant liver dysfunction as measured by: ALT >2.0 × ULN, alkaline phosphatase > 2.0 × ULN, AST >2.0 × the ULN, or GGT >2.0 × the ULN or serum bilirubin ≥ 1.2 × the ULN at screening, or a clinically significant change in liver function between screening and baseline. 15. Subjects with alteration of the coagulation panel (INR) and/or PT ≥ 1.5 × the ULN; aPTT ≥ 1.5 × ULN, or serum albumin ≤ 3 gm/dL. For subjects on warfarin or other anticoagulants, an INR (or PT/PTT) considered by the Principal Investigator as therapeutically appropriate will be allowed. 16. Subjects with values of CPK and/or CK-MB >2.5 times normal institutional limits at screening. 17. Any subject who by Investigator's judgement, has a significant hematuria or proteinuria at screening. 18. Concurrent treatment with Class I or III antiarrhythmic drugs (unless the medication was discontinued more than 3 months before proposed enrollment). 19. Positive screening for HIV antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies. 20. Known history of or active alcohol abuse (no more than 14 units/week for males or 7 units/week for females) or use of illicit drugs within 1 year prior to randomization other than recreational use of marijuana or cannabis-based products. 21. Other medical or psychiatric condition that, in the opinion of the Investigator, would preclude obtaining voluntary consent/assent or would confound the secondary objectives of study. 22. A history of malignancy of any type or any pre-malignant condition (e.g. ductal carcinoma in situ, colonic polyp, or cervical atypia). All subjects are to undergo cancer screening following study enrollment in accordance with American Cancer Society Guidelines. 23. Pregnant or lactating female subjects at screening. 24. Subjects with clinically significant or poorly controlled disease including, but not limited to, endocrine (including diabetes and thyroid) disease, neurological or psychiatric (even mild), GI, hematological, urological, immunological, or ophthalmic diseases as determined by the Investigator. 25. Subjects who are not non-smokers or light smokers (no more than 5 cigarettes per day) and who cannot abstain from smoking from 2 weeks prior to the administration of IP through the end of the study.
Drug: JK07, Drug: Matching Placebo
Heart Failure With Reduced Ejection Fraction, Heart
heart failure, HFrEF, neuregulin 1, NRG-1, heregulin, HER3, HER4, ErbB3, ErbB4, reduced ejection fraction
UT Southwestern
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PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban

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studyfinder@utsouthwestern.edu
Michael Wait
17648
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04142658
STU-2020-0560
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Inclusion Criteria:

• Male or female at least 18 years of age at the time of giving informed consent.
• Participants currently receiving warfarin anticoagulation and who are able to receive warfarin with a target INR 2.0 to 3.0.
• Participants are able to take low-dose aspirin at a dose of 75 -100 mg daily or have a documented contraindication to aspirin use.
• Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.
• Female participants of childbearing potential, including those who are less than 2 years post-menopausal, must agree to, and comply with using a highly effective method of birth control (eg, barrier contraceptives [condom or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices or sexual abstinence) while partaking in this study. In addition, all women of childbearing potential must agree to continue to use birth control throughout the study until last study visit.
• Informed of the full nature and purpose of the study, including possible risks and side effects, given ample time and opportunity to read and understand this information, and sign and date the written informed consent before inclusion in the study.
Exclusion Criteria:

• Mechanical valve in any position other than aortic valve.
• Any cardiac surgery in the three months (90 days) prior to enrollment.
• Need to be on aspirin >100 mg daily or a P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel, or ticlopidine).
• Known hypersensitivity or other contraindication to apixaban.
• On dialysis or a creatinine clearance < 25 mL/min.
• Ischemic stroke or intracranial hemorrhage within 3 months.
• Active pathological bleeding at the time of screening for enrollment.
• Active endocarditis at the time of screening for enrollment.
• Pregnant, plan to become pregnant, or are breast feeding.
• On concomitant combined strong P-gp and CYP3A4 inducers or inhibitors.
• History of non-compliance with recommended monthly INR testing.
Drug: Apixaban 5 MG, Drug: Apixaban 2.5 MG, Drug: Warfarin, Device: On-X Aortic Mechanical Valve
Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Failure
UT Southwestern
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Acute Kidney Injury Genomics and Biomarkers in TAVR Study

In the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly utilized alternative procedure for replacing a stenotic aortic valve. This study collects clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR and to identify key clinical and procedural predictors of AKI. This study seeks to identify blood and urine biomarkers that can be used for early detection of AKI around the time of the procedure. The study seeks to assess for novel genetic variants associated with development of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and biomarkers that are associated with adverse cardiovascular events after TAVR and to further explore how these events may inter-relate with acute kidney injury.
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studyfinder@utsouthwestern.edu
Amanda Fox
149974
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT02791880
STU 112015-015
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Inclusion criteria: Subjects are eligible to participate if they are undergoing TAVR for aortic stenosis at the University of Texas Southwestern Medical Center.
Exclusion Criteria:
1. The patient cannot or will not provide informed consent. 2. The patient is aged less than 18 years. 3. The patient's pre-procedural hematocrit is less than 25%. 4. The patient has known hepatitis C and/or human immunodeficiency virus infection 5. In the opinion of the principal investigator, the patient will be unlikely to complete long-term follow up for medical or social reasons.
Procedure: Transcatheter Aortic Valve Replacement
Heart Failure, Myocardial Infarction, Stroke, Acute Kidney Injury, Renal Insufficiency, Chronic, Arrhythmias, Cardiac, Cardiovascular
acute kidney injury, transcatheter aortic valve replacement, genomics, biomarker
Parkland Health & Hospital System
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Nit-Occlud PDA Post-Approval Study

The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and effectiveness of the device in the post-approval phase.
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studyfinder@utsouthwestern.edu
Surendranath Veeram Reddy
109868
All
6 Months to 21 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02100683
STU 012014-045
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Inclusion Criteria:

• Angiographically confirmed PDA with minimum diameter < 4 mm.
• Weight is ≥ 5 kg.
• Age 6 months to 21 years.
Exclusion Criteria:

• Cardiac anomalies requiring surgery.
• Known bleeding or coagulation disorder.
• Febrile illness within 7 days of planned procedure.
• Pregnancy.
• Pulmonary hypertension with increased pulmonary vascular resistance (≥ 5 Wood Units).
• Hypersensitivity to contrast medium.
• Known nickel allergy.
Device: PDA Coil
Patent Ductus Arteriosus (PDA)
Occluder
Children’s Health
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Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology

A randomized, blinded, controlled trial to evaluate growth velocity and clinical outcomes in infants with single ventricle physiology fed an exclusive human milk diet prior to, and throughout the post-operative period following, surgical repair. Human milk is defined as expressed human milk or donor milk and its derivatives, human milk-based fortifier and human milk caloric fortifier. The study hypothesis is that infants fed an exclusive human milk diet will have short and long term benefits, with improved wound healing, growth, and neurodevelopmental outcomes while reducing episodes of feeding intolerance and necrotizing enterocolitis (NEC).
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Erin Gordon
155770
All
up to 7 Days old
N/A
This study is NOT accepting healthy volunteers
NCT02860702
STU 072016-089
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Inclusion Criteria:
1. Term infants (≥37 and 0/7 weeks gestational age) ≤ 7 days old with a diagnosis of single ventricle physiology who are thought to require a single ventricle repair at the time of enrollment. 2. Infant feeding was NPO or consisted of 100% human milk diet prior to enrollment 3. Parent(s) willing to sign informed consent. 4. Parent(s) willing to comply with study follow-up procedures. 5. Require surgical palliation within the first 1 month of life.
Exclusion Criteria:
1. Term infants >7 days old at the time of diagnosis. 2. <37 weeks gestation 3. Infants requiring cardio-pulmonary resuscitation prior to surgical repair. 4. Outborn infants who received enteral nutrition at the other institution prior to surgical repair. If it is uncertain if infant received even 1 bottle or a small amount of formula, infants will be excluded. 5. Major congenital abnormalities that could significantly affect survival such as: 1. Confirmed or suspected major genetic abnormalities (lethal or with extremely low probability for survival). 2. Chromosomal abnormalities: Trisomies (13, 18, 21 etc.) deletions or translocations (Turner/Williams Syndrome, DiGeorge, to name a few) 3. Major organ system abnormalities not related to a genetic syndrome that are lethal or have extremely low probability for survival (i.e, bilateral kidney intrinsic disease, pulmonary hypoplasia, Central Nervous System (CNS) malformations: Arnold Chiari, myelomeningoceles, hydranencephaly, schizencephaly, holoprosencephaly)) 4. Heterotaxia 5. Metabolic disorders affecting growth: homocystinuria, methylmalonic acidemias, propionic acidemias, urea cycle defects 6. Evidence of intracerebral hemorrhage (IVH) ≥ Grade 3 7. Any comorbidity or significant clinical event prior to enrollment, deemed by the Investigator as likely to affect survival. 8. Requires Extracorporeal Membrane Oxygenation (ECMO) pre-operatively 9. Legally Authorized Representative(s) unwilling to comply with an exclusive human milk diet either in the form of mother's milk, human milk-based human milk fortifier, human milk based caloric fortifier or donor human milk during the initial hospitalization period and through the 30 day feeding period after surgical repair or hospital discharge, whichever comes first.
Other: Human Milk Derived Fortifier, Other: Human/Bovine Milk
Congenital Heart Defect
Single Ventricle, Congenital Heart Defect
Children’s Health
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Ruptured Aneurysms Treated With Hydrogel Coils (RAGE)

To determine safety and occlusion rates when second-generation hydrogel coils are used in the treatment of ruptured intracranial aneurysms.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Babu Welch
67812
All
18 Years to 75 Years old
This study is NOT accepting healthy volunteers
NCT03252314
STU 012018-100
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Inclusion Criteria:
1. Patient is ≥ 18 and ≤ 75 years of age. 2. Patient has a previously untreated, ruptured saccular intracranial aneurysm that is 2
•14 mm in diameter and is suitable for coil embolization as determined by the treating physician. 3. Patient has a baseline Hunt and Hess Score of I, II, or III. 4. Patient or patient's legally authorized representative has provided written informed consent. 5. Patient must be considered by the treating physician to be available for and able to complete all followup visits. 6. Patient has not been previously entered into this study.
Exclusion Criteria:
1. Inability to obtain written informed consent. 2. Patient is < 18 or > 75 years of age. 3. Patient has a baseline Hunt and Hess score of IV or V. 4. Target aneurysm is dissecting, fusiform, mycotic, blister-like, tumoral, or AVM-related. 5. Target aneurysm maximum diameter is > 14mm or < 2 mm. 6. Target aneurysm was previously treated via clipping or coiling. 7. Target aneurysm is deemed by the treating physician to be unsuitable for coiling or unlikely to be successfully treated by endovascular techniques. 8. Target aneurysm has not been confidently determined by the treating physician to be the source of SAH. 9. Intended use of a flow diverter or intrasaccular device as a component of the target aneurysm treatment plan. 10. Intended use of a coil-assist stent as a component of the target aneurysm treatment plan, unless use of a stent is 1) planned as a subsequent stage of a staged coiling procedure or 2) used for bailout purposes. 11. Patient has a known, untreatable hypersensitivity to contrast dye, iodine, hydrogel, or any other component of the treatment device. 12. Patient has a contraindication to heparin, aspirin, or clopidogrel. 13. Patient has vascular anatomy/tortuosity preventing access to the target aneurysm. 14. Patient unable to undergo DSA or DSA is determined unsuitable by the treating physician. 15. Patient has a serious or life-threatening comorbidity that could confound study results. 16. Patient is at high risk of noncompliance due to a history of substance abuse, psychosocial issues, etc. 17. Patient is unable to complete scheduled followup assessments due to comorbidities, geographical limitations, or a life expectancy of less than 18 months. 18. Patient is pregnant, breastfeeding, or plans to become pregnant prior to completion of followup. 19. Patient is enrolled in another device or drug study in which participation could confound study results.
Device: Second-generation hydrogel coils
Ruptured Aneurysm
Parkland Health & Hospital System
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