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Evaluation of the Diagnostic Value of the TPD System in Determining ADHF Causing Acute Dyspnea

The objective of this study is to evaluate Lung Doppler signals (LDS) among patients presenting to the emergency department with acute dyspnea, in order to determine the diagnostic value of this non-invasive method to discriminate ADHF causing dyspnea from any other cause i.e., non-ADHF causes of dyspnea.
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studyfinder@utsouthwestern.edu
Deborah Diercks
152662
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03998410
STU-2019-0989
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Inclusion Criteria:

• Age ≥ 18 years
• Patients with acute onset dyspnea (defined as shortness of breath (SOB) at rest or on exertion) and diagnostic uncertainty of etiology where heart failure is in consideration.
• Patients designated to undergo chest X-ray as part of standard of care assessment.
Exclusion Criteria:

• Obvious trauma contributing to dyspnea
• Inability to provide written informed consent
• Not speaking English or Spanish
• Right-sided lobectomy
• Patients with implanted ventricular assist device
• Patient is unable to undergo the TPD test
• Patient is already enrolled in a clinical study with experimental medications
Device: Lung Doppler Signals
ADHF, Lung/Thoracic
ADHF Dyspnea ED
Parkland Health & Hospital System
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Hyperpolarized Carbon 13-Based Metabolic Imaging to Detect Radiation-Induced Cardiotoxicity

Patients enrolled in the study will receive standard of care adjuvant or definitive breast, chest wall or thoracic radiation therapy.Cardiac mitochondrial dysfunction is a hallmark of radiation-induced cardiac injury. Reactive oxygen species (ROS) produced by ionizing radiation cause oxidation of mitochondrial proteins and alter oxidative phosphorylation and pyruvate metabolism(5). The goal of this study is to detect early changes in the mitochondrial metabolism in situ as a marker for subclinical radiation-induced cardiotoxicity.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Prasanna Alluri
42027
All
18 Years to 100 Years old
Early Phase 1
This study is NOT accepting healthy volunteers
NCT04044872
STU-2019-1099
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Inclusion Criteria:

• Tissue diagnosis of benign or malignant tumor of the breast (left-sided only) or thorax 1. Stage I to III 2. ECOG performance status 0-1 3. The patient must be deemed an appropriate candidate for adjuvant ordefinitive radiation therapy with or without regional nodal irradiation 4. Radiation therapy planning should be CT scan-based using 3D conformal radiotherapy (3D-CRT), intensity modulated radiotherapy (IMRT) or volumetric arc therapy (VMAT). 5. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 5.1 A female of child-bearing potential is any woman (regardless of sexual orientation, 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). 5.2. A female of postmenopausal status is defined as patients over 60 or greater OR patients age 50-59 who meet the following criteria:
• s/p bilateral oophorectomy, OR
• with intact uterus without menses in the past 12 months OR,
• with biochemical confirmation of post-menopausal status (estradiol in the menopausal range based on local laboratory criteria) 6. Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
1. Prior thoracic radiation therapy 2. Neoadjuvant, adjuvant or prior HER-2 directed therapy 3. Subjects may not be receiving any investigational agents for the treatment of the cancer under study. 4. Tissue expander placement after mastectomy 5. Diagnosis of connective tissue disorders, including systemic lupus erythematosis, scleroderma, or dermatomyositis 6. Known metastases 7. 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 8. eGFR <30 9. Any contraindication to MRI (including, but not limited to metal implants and devices contraindicated at 3T, breast tissue expanders, non-MR compatible IV port, claustrophobia) 10. History of psychiatric or addictive disorders that would preclude obtaining informed consent 11. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Diagnostic Test: [1-13C]pyruvate along with MRI imaging
Thoracic Cancer, Breast - Female, Cardiovascular, Heart, Left Sided Breast Cancer
Cardiotoxicity, Cardiac injury, Radiation induced heart disease (RIHD)
UT Southwestern
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REDWOOD-HCM: Randomized Evaluation of Dosing With CK-3773274 in Obstructive Outflow Disease in HCM (REDWOOD-HCM)

This study is being performed to understand the effect of different doses of CK-3773274 on patients with obstructive hypertrophic cardiomyopathy (oHCM).
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studyfinder@utsouthwestern.edu
Aslan Turer
110995
All
18 Years to 85 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04219826
STU-2019-1646
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Inclusion Criteria
• Males and females between 18 and 85 years of age at screening.
• Body weight is ≥45 kg at screening.
• Diagnosed with oHCM per the following criteria:
• Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence of other cardiac disease.
• Has minimal wall thickness ≥15 mm (minimal wall thickness ≥13 mm is acceptable with a positive family history of HCM or with a known disease-causing gene mutation).
• Adequate acoustic windows for echocardiography.
• Has LVOT-G during screening as follows:
• Resting gradient ≥50 mmHg OR
• Resting gradient ≥30 mmHg and <50 mmHg with post-Valsalva LVOT-G ≥50 mmHg
• LVEF ≥60% at screening.
• New York Heart Association (NYHA) Class II or III at screening.
• Patients on beta-blockers, verapamil, diltiazem, or ranolazine should have been on stable doses for >4 weeks prior to randomization and anticipate remaining on the same medication regimen during the study.
• For Cohort 3: Patients must be taking disopyramide. Patients should have been on stable disopyramide doses for >4 weeks prior to screening and anticipate remaining on the same medication regimen during the study. Exclusion Criteria
• Aortic stenosis or fixed subaortic obstruction.
• Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
• History of LV systolic dysfunction (LVEF <45%) at any time during their clinical course.
• Documented history of current obstructive coronary artery disease (>70% stenosis in one or more epicardial coronary arteries) or documented history of myocardial infarction.
• Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the study period.
• For Cohorts 1 and 2: Has been treated with disopyramide or antiarrhythmic drugs that have negative inotropic activity within 4 weeks prior to screening. (For Cohort 3, use of disopyramide is required).
• Paroxysmal atrial fibrillation or flutter documented during the screening period.
• Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) ≤6 months prior to screening. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for >6 months).
• History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening.
• Has received prior treatment with CK-3773274 or is currently receiving mavacamten.
Drug: CK-3773274 (5 - 15 mg), Drug: CK-3773274 (10 - 30 mg), Drug: Placebo for CK-3773274
Obstructive Hypertrophic Cardiomyopathy, Heart
CK-3773274, CK-274, obstructive hypertrophic cardiomyopathy, oHCM, REDWOOD-HCM
UT Southwestern
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Pragmatic Airway Resuscitation Trial (PART)

The primary objective of the trial is to determine if 72-hour survival after out-of-hospital cardiac arrest (OHCA) is improved with initial endotracheal intubation (ETI) over initial laryngeal tube (LT) airway management strategies.
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Ahamed Idris
58880
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02419573
STU 042015-059
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Inclusion Criteria:

• Out-of-hospital cardiac arrest (OHCA)
• Adult (age ≥18 years or per local interpretation)
• Non-traumatic etiology
• Initiation of ventilatory support (e.g., bag-valve-mask device, non-rebreather mas, etc.)
Exclusion Criteria:

• Known pregnant women
• Known prisoners
• Major facial trauma (visible major deformity, copious oral bleeding, etc)
• Major bleeding or exsanguination (e.g., major upper or lower GI bleed, visceral perforation, major uncontrolled bleeding from laceration or injury)
• Patient receiving initial care by a non-PART participating EMS agency capable of performing ETI, LT, or other advanced airway management
• Patients with ET tube, LT or other advanced airway device inserted prior to participating EMS agency arrival (e.g., inserted by healthcare facility personnel)
• Patients with a pre-existing tracheostomy
• Obvious asphyxial cardiac arrest (e.g., choking, foreign body aspiration, angioedema, epiglottitis, trauma to mouth and face, etc.)
• Patients with a left ventricular assist device (LVAD) or total artificial heart (TAH)
• Patients with pre-existing written "do-not-attempt-resuscitation" (DNAR) orders
• Inter-facility transports
• Patients with a "do not enroll" bracelet
Device: Endotracheal Intubation, Device: Laryngeal Tube (King)
Cardiac Arrest
cardiac arrest, cardiopulmonary resuscitation, laryngeal tube, endotracheal intubation, non-traumatic Out of Hospital Cardiac Arrest (OOHCA)
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Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate

Chlorthalidone (CTD) may produce various metabolic disturbances, including hypokalemia, activation of Renin-Angiotensin- Aldosterone (RAA) system, oxidative stress, dyslipidemia, Fibroblast growth factor 23 (FGF23) synthesis, and magnesium depletion. These factors may interact with each other to contribute to the development of insulin resistances and metabolic syndrome. Smaller studies have suggested that Potassium magnesium Citrate (KMgCit) can ameliorate CTD- induced metabolic side effects independent of correction of hypokalemia. This study will tests if KMgCit ameliorates CTD induced metabolic effects independent of correction of hypokalemia.
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danielle.pittman@utsouthwestern.edu
or
Call 214-648-5005
studyfinder@utsouthwestern.edu
Wanpen Vongpatanasin
17620
All
21 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02665117
STU 092015-058
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Inclusion Criteria:
• Treated or untreated stage I hypertension
Exclusion Criteria:

• Diabetes mellitus,
• Renal impairment (serum creatinine > 1.4 mg/dL),
• Any heart diseases such as congestive heart failure, sustained arrhythmia, or coronary heart disease,
• Chronic regular NSAID use,
• Allergy to thiazide diuretics,
• Gastro-esophageal reflux disease (GERD) requiring treatment with acid reducing agents or antacid more than once a week,
• Esophageal-gastric ulcer or history of gastrointestinal bleeding,
• Chronic diarrhea, vomiting,
• Excessive sweating,
• Unprovoked hypokalemia (serum K < 3.5 mmol/L) or hyperkalemia (serum K > 5.3 mmol/L),
• Abnormal liver function test (Aspartate transaminase (AST) or Alanine transaminase (ALT) above upper limit of normal range),
• Subjects on any potassium supplement on a regular basis for any reason, such as patients with primary aldosteronism,
• Pregnancy,
• History of major depression, bipolar disorder, or schizophrenia,
• History of substance abuse,
• Gout,
• Metabolic alkalosis, with serum bicarbonate > 32 meq/L,
• Severe dietary salt restriction, less than1/2 spoonful or 50 meq sodium/day.
• Patient with Claustrophobia will not have MRI but can still participate in the study without MRI
• Metal implants will not have MRI but can still participate in the study without MRI
Drug: Potassium Magnesium Citrate (KMgCit), Drug: Potassium Chloride (KCl), Drug: Chlorthalidone
Hypertension, Cardiovascular, Other Endocrine System
Hypokalemia, Isoprostanes, Insulin resistance, Aldosterone, Hepatic fat, Muscle Magnesium, Liver fat
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Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV

The primary objective of this study is to evaluate the dose effect of Phenylephrine Hydrochloride Injection on the treatment of clinically relevant decreased blood pressure in the pediatric population, ≥12 to 16 year old patients undergoing general and neuraxial anesthesia. The secondary objectives are to describe changes in blood pressure and heart rate, time to onset and to maximal response, and the duration of response; to assess the safety of the product in this population; and to characterize the pharmacokinetics of phenylephrine hydrochloride.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Peter Szmuk
80418
All
12 Years to 16 Years old
Phase 4
This study is also accepting healthy volunteers
NCT02323399
STU 082014-004
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Inclusion Criteria:
1. Subject's age is between ≥12 and 16 years, inclusive 2. Subject is scheduled for a procedure that requires general or neuraxial anesthesia 3. Subjects must have normal or clinically acceptable physical exam 4. Subjects with controlled diabetes prior to entry must have a mean systolic/diastolic office blood pressure ≤128/78 mmHg (sitting, after 5 minutes of rest) 5. Females must have a urine or serum pregnancy test (Human Chorionic Gonadotropin) that is negative at Screening and Day 1 6. Subject's parent or legal guardian gives informed consent and subject gives assent.
Exclusion Criteria:
1. Subject has a contraindication to vasoconstrictor therapy for control of blood pressure 2. Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment 3. Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures 4. Subjects who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment administration 5. Subjects who are positive for hepatitis B surface antigen or hepatitis C antibody 6. Subjects taking antihypertensive medication 7. Subject is moribund (death is likely to occur in less than 48 hours) 8. Females who are pregnant, nursing or unwilling to use/practice adequate contraception.
Drug: Phenylephrine
Hypotension
Children’s Health
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Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial (THAPCA-IH)

Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in which the body's temperature is lowered and maintained several degrees below normal for a period of time, has been used to successfully treat adults who have experienced cardiac arrest. This study will evaluate the efficacy of therapeutic hypothermia at increasing survival rates and reducing the risk of brain injury in infants and children who experience a cardiac arrest while in the hospital.
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studyfinder@utsouthwestern.edu
Lakshmi Raman
102213
All
up to 18 Years old
N/A
This study is NOT accepting healthy volunteers
NCT00880087
STU 102010-089
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Inclusion Criteria:

• Patient suffered cardiac arrest requiring chest compressions for at least 2 minutes (120 seconds) with ROSC/ROC; AND
• Age greater than 48 hours (with a corrected gestational age of at least 38 weeks) and less than 18 years; AND
• Patient requires continuous mechanical ventilation; AND
• The cardiac arrest was unplanned (i.e., not part of cardiac surgical procedure)
Exclusion Criteria:

• The parent or legal guardian does not speak English or Spanish (the only two languages in which VABS II is standardized)
• Randomization is impossible within six hours of ROSC; OR
• Patient is on extracorporeal membrane oxygenation (ECMO) when arrest occurs; OR
• Continuous infusion of epinephrine or norepinephrine at very high doses (≥2 ug/kg/minute) received immediately prior to randomization; OR Glasgow Coma Scale motor response of five (localizing pain or for infants less than two years, withdraws to touch) or six (obeys commands, or for infants, normal spontaneous movement) prior to randomization; OR
• History of a prior cardiac arrest with chest compressions for at least two minutes during the current hospitalization but outside the 6 hour window for randomization; OR
• Pre-existing terminal illness with life expectancy < 12 months; OR
• Lack of commitment to aggressive intensive care therapies including do not resuscitate orders and other limitations to care; OR
• Cardiac arrest was associated with severe brain, thoracic, or abdominal trauma; OR
• Active and refractory severe bleeding prior to randomization; OR
• Near drowning in ice water with patient core temperature ≤32 °C on presentation; OR
• Patient is pregnant; OR
• Patient participation in a concurrent interventional trial whose protocol, in the judgment of the THAPCA investigators, prevents effective application of one or both THAPCA therapeutic treatment arms, or otherwise significantly interferes with carrying out the THAPCA protocol; OR
• Patient is newborn with acute birth asphyxia; OR _ Patient cared for in a neonatal intensive care unit (NICU) after arrest (ie, would not be admitted to PICU); OR
• Patient has sickle cell anemia; OR
• Patient known to have pre-existing cryoglobulinemia; OR
• Central nervous system tumor with ongoing chemotherapy or radiation therapy; OR
• Chronic hypothermia secondary to hypovolemic, pituitary, or related condition for which body temperature is consistently below 37 °C ; OR progressive degenerative encephalopathy; OR
• Any condition in which direct skin surface cooling would be contraindicated, such as large burns, decubitus ulcers, cellulitis, or other conditions with disrupted skin integrity (NOTE: patients with open chest CPR should be included but placement of cooling mattresses will be modified as needed); OR
• Previous enrollment in the THAPCA Trials.
Procedure: Therapeutic Hypothermia, Procedure: Therapeutic Normothermia
Cardiac Arrest, Brain and Nervous System
Cardiac Arrest, Cardiopulmonary Arrest, Pediatric Cardiac Arrest, VABS, Vineland Adaptive Behavior Scale, POPC/PCPC, hypoxic-ischemic encephalopathy
Children’s Health
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Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure

This study consist of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study. The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in pediatric heart failure patients over 52 weeks of treatment.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Mohammad Hussain
164347
All
1 Month to 17 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT02678312
STU 022016-077
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Key
Inclusion Criteria:

• Chronic heart failure resulting from left ventricular systolic dysfunction, and receiving chronic HF therapy (if not newly diagnosed)
• NYHA classification II-IV (older children: 6 to <18 years old) or Ross CHF classification II-IV (younger children: < 6 years old)
• Systemic left ventricular ejection fraction ≤ 40% or fractional shortening ≤20%
• For Part 1 study: Patients must be treated with an ACEI or ARB prior to screening. Patients in Group 1 and 2 must be currently treated with the dose equivalent of at least enalapril 0.2 mg/kg prior to the LCZ696 3.1 mg/kg administration. Group 3 patients will participate in LCZ696 0.8 mg/kg and not LCZ696 3.1 mg/kg.
• Biventricular physiology with systemic left ventricle Key
Exclusion Criteria:

• Patient with single ventricle or systemic right ventricle
• Patients listed for heart transplantation (as United Network for Organ Sharing status 1A) or hospitalized waiting for transplant (while on inotropes or with ventricular assist device)
• Sustained or symptomatic dysrhythmias uncontrolled with drug or device therapy
• Patients that have had cardiovascular surgery or percutaneous intervention to palliate or correct congenital cardiovascular malformations within 3 months of the screening visit. Patients anticipated to undergo corrective heart surgery during the 12 months after entry into Part 2
• Patients with unoperated obstructive or severe regurgitant valvular (aortic, pulmonary, or tricuspid) disease, or significant systemic ventricular outflow obstruction or aortic arch obstruction
• Patients with restrictive or hypertrophic cardiomyopathy
• Active myocarditis
• Renal vascular hypertension (including renal artery stenosis)
• Moderate-to severe obstructive pulmonary disease
• Serum potassium > 5.3 mmol/L
• History of angioedema
• Allergy or hypersensitivity to ACEI / ARB
Drug: LCZ696, Drug: Enalapril, Drug: Placebo of LCZ696, Drug: Placebo of Enalapril
Pediatric Heart Failure, Cardiovascular
Pediatric Heart failure,, systemic left ventricle,, reduced ejection fraction
Children’s Health
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Hypertension, Intracranial Pulsatility and Brain Amyloid-beta Accumulation in Older Adults (HIPAC Trial) (HIPAC)

The aim of this study is to determine if lowering blood pressure using FDA approved medication (antihypertensive drugs) alters brain pulsatility and reduces brain amyloid beta protein accumulation in older adults. Amyloid beta protein is high in the brain of older adults with Alzheimer's disease. Hypertension may increase brain amyloid beta protein accumulation and affect memory and thinking ability in older adults. However, whether lowering blood pressure reduces brain amyloid beta protein and improves brain function is inconclusive. The investigators hypothesize that treating high blood pressure alters brain pulsatility, which in turn reduces brain amyloid beta protein accumulation and improves brain structure and function.
Call 214-648-5940
danielle.pittman@utsouthwestern.edu
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Rong Zhang
18315
All
55 Years to 79 Years old
Phase 2
This study is also accepting healthy volunteers
NCT03354143
STU 102017-029
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Inclusion Criteria:
1. Age 55-79, all races/ethnicities, and both women and men are eligible; 2. Mini-mental state exam (MMSE) > 26 to exclude cognitive impairment or dementia; 3. Healthy normotensive subjects (24-hour ambulatory BP<125/75 mmHg without use of antihypertensive medication); 4. Patients with hypertension defined as 24-hour SBP ≥130 mmHg , patients on BP medications are eligible; 5. Patients with hypertension are willing to be randomized into either treatment group and ability to return to clinic or laboratory for follow-up visits over 12 months; 6. Fluency in English, adequate visual and auditory acuity to allow neuropsychological testing; 7. Screening laboratory tests and ECG without significant abnormalities that might interfere with the study
Exclusion Criteria:
1. History of stroke, transient ischemic attack, traumatic brain injury or severe cerebrovascular disease by clinical diagnosis or past MRI/CT; 2. Diagnosis of AD or other type of dementia and neurodegenerative diseases; 3. Evidence of severe depression or other DSM-V Axis I psychopathology 4. Unstable heart disease based on clinical judgment (heart attack/cardiac arrest, cardiac bypass procedures within previous 6 months and congestive heart failure), evidence of atrial fibrillation on ECG, or other severe medical conditions; 5. Chronic kidney diseases with GFR < 40 ml/min; 6. Orthostatic hypotension, defined as standing SBP<100 mmHg; 7. History of significant autoimmune disorders such as systemic lupus erythematosus, rheumatoid arthritis and polymyalgia rheumatica; 8. History of drug or alcohol abuse within the last 2 years; 9. Diagnosis of uncontrolled diabetes mellitus (fasting blood sugar ≥126 mg/dL or A1C >7.5%) 10. Obstructive sleep apnea; 11. Regularly smoking cigarette within the past year; 12. Severe obesity with BMI ≥ 45; 13. Participants enrolled in another investigational drug or device study within the past 2 months; 14. Carotid stent or sever stenosis (> 50%); 15. Pacemaker or other medical device of metal that precludes performing MRI; 16. History of B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowable); 17. Any conditions judged by the study investigators to be either medically inappropriate, or risky for participant or likely to have poor study adherence; 18. Claustrophobia; 19. Pregnancy
Drug: Standard Care, Drug: Intensive Treatment
Hypertension, Brain and Nervous System, Cardiovascular
Dementia, Alzheimer's Disease, Blood Pressure, Cognitive Function, Magnetic Resonance Imaging
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A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
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Sonja Bartolome
115047
All
18 Years to 75 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03626688
STU 062018-068
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Inclusion Criteria:
1. At least 18 years of age. 2. 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. 3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures 4. Primary diagnosis of symptomatic PAH 5. Has had a right heart catheterization (RHC) performed at or within 3 years prior to Screening (RHC will be performed during Screening if not available) that is consistent with the diagnosis of PAH 6. Has WHO/ NYHA functional class II to IV symptoms. 7. If on PAH-specific background oral therapy, subject is on stable therapy with either an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a soluble guanylate cyclase (sGC) stimulator. Subjects may be naïve to PAH-specific treatment. 8. Has a 6MWD of ≥150 meters. 9. If taking concomitant medications that may affect the clinical manifestations of PAH (eg, calcium channel blockers, diuretics, digoxin, or L arginine supplementation, beta blockers, angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers), must be on a stable dose for at least 30 days prior to the Baseline Visit and the dosage maintained throughout the study. The exception is that the dose of diuretics must be stable for at least the 10 days prior to Baseline. 10. Both male and female subjects agree to use a highly effective method of birth control throughout the entire study period from informed consent through to 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 during the study and for 30 days after the last dose of IMP. Eligible male subjects must agree not to participate in sperm donation for 90 days after the last dose of IMP.
Exclusion Criteria:
1. For subjects with known HIV-associated PAH, a cluster designation 4 (CD4+) T-cell count <200/mm3 within 90 days of Baseline. 2. Must not have 3 or more left ventricular dysfunction risk factors as defined in the study protocol. 3. Has evidence of more than mild lung disease on pulmonary function tests performed within 180 days prior to, or during Screening. 4. Has evidence of thromboembolic disease as determined by a V/Q lung scan or local standard of care diagnostic evaluation at or after diagnosis of PAH. 5. Current diagnosis of ongoing and clinically significant sleep apnea as defined by the Investigator. 6. Male subjects with a corrected QT interval using Fridericia's formula (QTcF) >450 msec and female subjects with a QTcF >470 msec on ECG recorded at Screening and analyzed by the central ECG laboratory. Subjects with evidence of intraventricular conduction delay, defined as a QRS interval greater than 110 msec, will be excluded if the QTcF is >500 msec for both males and females. 7. Severe chronic liver disease (ie, Child-Pugh Class C), portal hypertension, cirrhosis or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage, encephalopathy). 8. Confirmed active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). 9. Subjects with alanine aminotransferase or aspartate aminotransferase ≥3 times the upper limit of normal (ULN) or total bilirubin ≥2 × ULN at Screening. 10. Chronic renal insufficiency as defined by serum creatinine >2.5 mg/dL or requiring dialysis at Screening. 11. Hemoglobin concentration <9 g/dL at Screening. 12. Subjects treated with an IV or SC prostacyclin pathway agent (eg, epoprostenol, treprostinil, or iloprost) for PAH at any time prior to Baseline (use in vasoreactive testing is permitted). 13. Subjects currently on or who were treated with an inhaled or oral prostacyclin pathway agent (iloprost, treprostinil, beraprost, or selexipag) within 90 days prior to Baseline. 14. Subject has pulmonary veno-occlusive disease. 15. Malignancy diagnosed and/or treated within 5 years prior to Screening, with the exception of localized non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix excised with curative intent. 16. Subject tests positive for amphetamine, cocaine, methamphetamine, methylenedioxymethamphetamine or phencyclidine in urine drug screen performed at Screening, or has a recent history (6 months) of alcohol or drug abuse. A subject will not be excluded due to a positive drug screen caused by prescribed medications. 17. Initiation or discontinuation of a cardio-pulmonary rehabilitation program based upon exercise within 90 days prior to Screening and/or planned during study participation. 18. Prior participation in any study of ralinepag or participation in another interventional clinical study with medicinal products within 30 days prior to Screening. Concurrent participation in registry or observational studies is allowed, as long as the subject can fulfill all other entry criteria and comply with all study procedures. 19. Any reason that, in the opinion of the Investigator or Medical Monitor, precludes the subject from participating in the study (eg, any previous or intercurrent medical condition) that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation. 20. Known hypersensitivity to ralinepag or any of the excipients. 21. Life expectancy <12 months based on the Investigator's opinion. 22. Women who are pregnant, lactating or breast-feeding.
Drug: Ralinepag, Drug: Placebo
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, Lung/Thoracic
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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Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) (A DUE)

Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet. This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.
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Trushil Shah
169968
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03904693
STU-2020-0178
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Inclusion Criteria:

• Signed and dated informed consent form (ICF)
• Confirmed diagnosis of symptomatic PAH in WHO FC II or III
• Symptomatic PAH belonging to one of the following subgroups of WHO Group 1 pulmonary hypertension:
• Idiopathic
• Heritable
• Drug- or toxin-induced
• Associated with connective tissue disease, HIV infection, portal hypertension or congenital heart disease with simple systemic-to-pulmonary shunt with persistent pulmonary hypertension documented by a right heart catheterization (RHC) ≥ 1 year after surgical repair
• PAH diagnosis confirmed by hemodynamic evaluation at rest (through central reading), evaluated within 5 weeks prior to randomization:
• Mean pulmonary artery pressure (mPAP) ≥ 25 mmHg, AND
• Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg, AND
• Pulmonary vascular resistance (PVR) ≥ 3 WU (i.e., ≥ 240 dyn∙sec∙cm-5)
• Negative vasoreactivity test in idiopathic, heritable, and drug/toxin-induced PAH. (Participants for whom no vasoreactivity test was performed at diagnosis can be eligible if currently treated with PAH therapy for more than 3 months and PAH diagnosis confirmed by hemodynamic evaluation at least 3 months after introduction of their PAH therapy).
• Currently receiving a stable dose of ERA or PDE-5i monotherapy for at least 3 months prior to baseline RHC, within the prespecified doses in the study protocol or no history of PAH-specific treatment
• Participant able to perform the 6MWT with a minimum distance of 100 m and maximum distance of 450 m at Screening
• A woman of childbearing potential must:
• have negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization
• agree to undertake monthly urine pregnancy tests during the study and up to at least 30 days after study treatment discontinuation
• agree to follow the contraception scheme from Screening up to at least 30 days after study treatment discontinuation
Exclusion Criteria:

• Treatment with a soluble guanylate cyclase stimulator, L-arginine, any form of prostanoids or prostacyclin-receptor agonists (including oral, inhaled, or infused routes) in the 3-month period prior to start of treatment
• Treatment with combination therapy of ERA and PDE-5i in the 3-month period prior to start of treatment or history of intolerance to ERA and PDE-5i combination therapy
• Hypersensitivity to any of the study treatments or any excipient of their formulations
• Treatment with a strong cytochrome P450 3A4 (CYP3A4) inducer in the 1-month period prior to start of treatment
• Treatment with a strong CYP3A4 inhibitor or a moderate dual CYP3A4/CYP2C9 inhibitor or co-administration of a combination of moderate CYP3A4 and moderate CYP2C9 inhibitors in the 1-month period prior to start of treatment
• Treatment with doxazosin
• Treatment with any form of organic nitrate, either regularly or intermittently
• Diuretic treatment initiated or dose changed within 1 week prior to the RHC or start of treatment
• Treatment with another investigational drug in the 3-month period prior to start of treatment
• Body mass index (BMI) > 40 kg/m2 at Screening
• Known presence of three or more of the following risk factors for heart failure with preserved ejection fraction at Screening:
• BMI > 30 kg/m2
• Diabetes mellitus of any type
• Essential hypertension (even if well controlled)
• Coronary artery disease, i.e. history of stable angina or known more than 50% stenosis in a coronary artery or history of myocardial infarction or history of or planned coronary artery bypass grafting and/or coronary artery stenting
• Known presence of moderate or severe obstructive lung disease any time prior to Screening as specified in study protocol
• Known presence of moderate or severe restrictive lung disease any time prior to Screening as specified in study protocol
• Clinically significant aortic or mitral valve disease; pericardial constriction; restrictive or congestive left-sided cardiomyopathy; life-threatening cardiac arrhythmias; significant left ventricular dysfunction; or left ventricular outflow obstruction, in the opinion of the investigator
• Known permanent atrial fibrillation, in the opinion of the investigator
• Known or suspected uncontrolled thyroid disease (hypo- or hyperthyroidism)
• Documented pulmonary veno-occlusive disease
• Hemoglobin < 100 g/L (<10 g/dL) at Screening
• Known severe hepatic impairment as specified in study protocol
• Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 × upper limit of normal (ULN) at Screening
• Severe renal impairment at Screening as specified in study protocol
• Systemic hypotension at Screening or Randomization and systemic hypertension at Screening as specified in study protocol
• Acute myocardial infarction or cerebrovascular event (e.g., stroke) within the last 26 weeks prior to Screening
• Known bleeding disorder, in the opinion of the investigator
• Loss of vision in one or both eyes because of non-arteritic anterior ischemic optic neuropathy
• Hereditary degenerative retinal disorders, including retinitis pigmentosa
• History of priapism, conditions that predispose to priapism (example, sickle cell anemia, multiple myeloma, or leukemia) or anatomical deformation of the penis (example, angulation, cavernosal fibrosis, or Peyronie's disease)
• Difficulty swallowing large pills/tablets that would interfere with the ability to comply with study treatment regimen
• Any planned surgical intervention (including organ transplant) during the double-blind treatment period, except minor interventions
• Exercise training program for cardiopulmonary rehabilitation in the 12-week period prior to start of treatment, or planned to be started during the double-blind period of the study
• Pregnant, planning to become pregnant or lactating
• Any known factor or disease that might interfere with treatment adherence, full participation in the study or interpretation of the results as judged by the investigator (e.g., drug or alcohol dependence etc.)
• Known concomitant life-threatening disease with a life expectancy less than (<) 12 months
• Calcium channel blocker treatment initiated, or dose changed within 3 months prior to right heart catheterization (RHC) at screening
Drug: FDC macitentan/tadalafil, Drug: Macitentan 10 mg, Drug: Tadalafil 40 mg, Drug: Placebo FDC, Drug: Placebo macitentan, Drug: Placebo tadalafil
Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), Cardiovascular, Lung/Thoracic
Pulmonary Arterial Hypertension, PAH, macitentan, tadalafil, fixed dose combination therapy
UT Southwestern
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A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging (RESTORE)

The purpose of the study is to assess the effects of selexipag on right ventricular (RV) function in participants with Pulmonary arterial hypertension (PAH).
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Kelly Chin
38273
All
18 Years to 65 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT04435782
STU-2021-0228
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Inclusion Criteria:

• World health organization functional class (WHO FC) II or III. Enrollment will be stratified by WHO FC II or III. Proportion of participants with WHO FC II and WHO FC III are expected to be approximately 40 percent (%) and 60%, respectively
• Pulmonary arterial hypertension (PAH) etiology belonging to one of the following groups according to 6th world symposium of pulmonary hypertension (WSPH) classification: a) Idiopathic PAH, b) Heritable PAH, c) Drugs or toxins induced d) PAH associated with connective tissue disease, e) PAH associated with congenital heart disease, with simple systemic-to-pulmonary shunt at least 1 year after surgical repair
• Patients already receiving PAH-specific oral mono or dual therapy (that is, phosphodiesterase type 5 inhibitors (PDE-5i) or soluble guanylate cyclase stimulators (sGCs) and/or endothelin receptor antagonist [ERA]) or patients who are not candidates for these therapies
• N-terminal-pro-hormone brain natriuretic peptide (NT-proBNP) more than (>) 300 nanogram per liter (ng/L) at screening
• Women of childbearing potential must meet the following criteria: a) Have a negative serum pregnancy test during screening and a negative urine pregnancy test on Day 1, b) Agree to use reliable methods of contraception from Day 1 to at least 30 days after study intervention discontinuation, c) If only using hormonal contraception, have used it for at least 1 month (30 days) before Day 1, and d) Agree to perform monthly pregnancy tests to at least 30 days after study intervention discontinuation
• 6-minute walking distance (6MWD) greater than or equal to (>=) 150 meter (m) during screening period
Exclusion Criteria:

• Prior use of Prostacyclin (IP)-receptor agonist, prostacyclin, or prostacyclin analog. Use of such treatments for vasoreactivity testing is not exclusionary; intermittent use of such treatments for digital ulcers or Raynaud's phenomenon is not exclusionary if stopped > 6 months (180 days) prior to Day 1
• Treatment with strong inhibitors of CYP2C8 (example, gemfibrozil) within 28 days prior to Day 1
• Treatment with another investigational drug planned or taken within 12 weeks (84 days) prior to Day 1
• Severe coronary heart disease or unstable angina
• Cerebrovascular events (example, transient ischemic attack, stroke) within 3 months prior to Day 1
Drug: JNJ-67896049
Pulmonary Arterial Hypertension, Cardiovascular, Heart
Right ventricle, Reverse remodeling, Magnetic resonance Imaging
UT Southwestern
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Anticoagulation in ICH Survivors for Stroke Prevention and Recovery (ASPIRE)

Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.
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Bappaditya Ray
126751
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03907046
STU-2019-1501
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Inclusion Criteria:

• Age at least 18 years
• Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI
• Can be randomized within 14-180 days after ICH onset
• Non-valvular AF (defined as atrial fibrillation or atrial flutter), documented by electrocardiography or a physician-confirmed history of prior AF
• CHA2DS2-VASc score ≥ 2
• Provision of signed and dated informed consent form by patient or legally authorized representative
• For females of reproductive potential: use of highly effective contraception
Exclusion Criteria:

• Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor
• History of earlier ICH within 12 months preceding index event
• Active infective endocarditis
• Clear indication for anticoagulant drugs (e.g., requires anticoagulation for deep vein thrombosis or pulmonary embolism) or antiplatelet drugs (e.g., requires aspirin or clopidogrel for recent MI).
• Previous or planned left atrial appendage closure
• Clinically significant bleeding diathesis
• Serum creatinine ≥2.5 mg/dL
• Active hepatitis or hepatic insufficiency with Child-Pugh score B or C
• Anemia (hemoglobin <8 g/dL) or thrombocytopenia (<100 x 10^9/L) that is chronic in the judgment of the investigator
• Pregnant or breastfeeding
• Known allergy to aspirin or apixaban
• Concomitant participation in a competing therapeutic trial
• Considered by the investigator to have a condition that precludes safe or active participation in the trial
• Persistent, uncontrolled systolic blood pressure (≥180 mm Hg)
• ICH caused by an arteriovenous malformation (AVM) that has not yet been secured
Drug: Apixaban, Drug: Aspirin
Atrial Fibrillation, Intracerebral Hemorrhage, Brain and Nervous System
UT Southwestern
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Anti-thrombotics for Adults Hospitalized With COVID-19 (ACTIV-4)

This is a randomized, open label, adaptive platform trial to compare the effectiveness of antithrombotic strategies for prevention of adverse outcomes in COVID-19 positive inpatients
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Ambarish Pandey
125045
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT04505774
STU-2020-1018
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Inclusion Criteria:

• ≥ 18 years of age
• Hospitalized for COVID-19
• Enrolled within 72 hours of hospital admittance or 72 hours of positive COVID test
• Expected to require hospitalization for > 72 hours
Exclusion Criteria:

• Imminent death
• Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
• Pregnancy
• Based on a recommendation from the ACTIV4 DSMB on December 19, 2020, enrollment of patients requiring ICU level of care into the therapeutic anti-coagulation arm was stopped due to meeting a futility threshold and a potential for harm for this sub-group could not be excluded. Enrollment continues for moderately ill hospitalized COVID-19 patients.
Drug: theraputic heparin, Drug: prophylactic heparin, Drug: P2Y12
Cardiovascular, Covid19
anti-coagulation, antithrombosis, anticoagulation, ACTIV, inpatient, heparin, p2y12
Parkland Health & Hospital System
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Milrinone in Congenital Diaphragmatic Hernia

Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia and persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant to conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO). Increased pulmonary vascular resistance (PVR) can lead to right ventricular overload and dysfunction. In patients with CDH, left ventricular dysfunction, either caused by right ventricular overload or a relative underdevelopment of the left ventricle, is associated with poor prognosis. Milrinone is an intravenous inotrope and lusitrope (enhances cardiac systolic contraction and diastolic relaxation respectively) with pulmonary vasodilator properties and has been shown anecdotally to improve oxygenation in PPHN. Milrinone is commonly used during the management of CDH although no randomized trials have been performed to test its efficacy. Thirty percent of infants with CDH in the Children's Hospital Neonatal Database (CHND) and 22% of late-preterm and term infants with CDH in the Pediatrix database received milrinone. In the recently published VICI trial, 84% of patients with CDH received a vasoactive medication. In the current pilot trial, neonates with an antenatal or postnatal diagnosis of CDH will be randomized to receive milrinone or placebo to establish safety of this medication in CDH and test its efficacy in improving oxygenation.
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Vedanta Dariya
153943
All
up to 168 Hours old
Phase 2
This study is NOT accepting healthy volunteers
NCT02951130
STU 042017-055
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Eligibility criteria: Infants are eligible if they meet all of the following criteria:
• ≥ 36 0/7 weeks PMA by best obstetric estimate AND birth weight of ≥ 2000g
• postnatal age ≤7 days (168 hours of age)
• invasive mechanical ventilation (defined as ventilation with an endotracheal tube) and
• one arterial blood gas with an OI ≥ 10 (after tracheal tube obstruction and other easily resolvable mechanical causes for increased OI are ruled out) on the most recent arterial blood gas within 12 hours prior to the time of randomization.
• if an arterial blood gas is not available at the time of randomization, a preductal OSI of ≥ 5 can be used as an inclusion criterion instead of OI ≥ 10; (the OSI should be based on the most recent preductal pulse oximetry recording and must be within 12 hours of randomization)
• postnatal blood gas with PCO2 ≤ 80 mmHg (arterial, capillary or venous blood gas) on the most recent blood gas sample obtained within 12 hours prior to randomization Note: Criteria (iv) to (vi) must be met at the most recent analysis within 12 hours prior to randomization.
Exclusion Criteria:
Infants are ineligible if they meet any of the following criteria:
• known hypertrophic cardiomyopathy
• Note 1: infants of diabetic mothers with asymmetric septal hypertrophy can be included as long as there is no evidence of obstruction to left ventricular outflow tract on echocardiogram,
• Note 2: infants with other acyanotic congenital heart disease (CHD) and CDH may be included in the study and will be a predetermined subgroup for analysis)
• cyanotic CHD
•transposition of great arteries (TGA), total anomalous pulmonary venous return (TAPVR), partial anomalous pulmonary venous return (PAPVR), truncus arteriosus (TA), tetralogy of Fallot (TOF), single ventricle physiology
•hypoplastic left heart syndrome (HLHS), tricuspid atresia, critical pulmonic stenosis or atresia etc.,
• enrolled in conflicting clinical trials (such as a randomized controlled blinded trial of another pulmonary vasodilator therapy); Note: mothers enrolled in fetal tracheal occlusion studies such as FETO may be enrolled if permitted by investigators of the fetal tracheal occlusion study; [FETO refers to fetoscopic endoluminal tracheal occlusion and involves occlusion of fetal trachea with a balloon device at mid-gestation and subsequent removal in later gestation]
• infants with bilateral CDH o Note 3: infants with anterior and central defects are included in the study
• associated abnormalities of the trachea or esophagus (trachea-esophageal fistula, esophageal atresia, laryngeal web, tracheal agenesis)
• renal dysfunction (with serum creatinine > 2 mg/dL not due to maternal factors) or severe oligohydramnios associated with renal dysfunction at randomization; renal dysfunction may be secondary to renal anomalies or medical conditions such as acute tubular necrosis
• severe systemic hypotension (mean blood pressure < 35 mm Hg for at least 2 h with a vasoactive inotrope score of > 30)
• decision is made to provide comfort/ palliative care and not full treatment
• Intracranial bleed (including the following findings on the cranial ultrasound)
• Cerebral parenchymal hemorrhage
• Blood/echodensity in the ventricle with distension of the ventricle
• Periventricular hemorrhagic infarction
• Posterior fossa hemorrhage
• Cerebellar hemorrhage
• persistent thrombocytopenia (platelet count < 80,000/mm3) despite blood product administration on the most recent blood draw prior to randomization
• coagulopathy (PT INR > 1.7) despite blood product administration on the most recent blood draw (if checked
•there is no reason to check PT for the purpose of this study)
• aneuploidy associated with short life span (such as trisomy 13 or 18) will not be included in the study (infants with trisomy 21 can be included in the study)
• elevated arterial, venous or capillary PCO2 > 80 mmHg in spite of maximal ventilator support (including high frequency ventilation) on the most recent blood gas obtained within 12 hours prior to randomization
• use of milrinone infusion prior to randomization (the use of other inhaled pulmonary vasodilators such as iNO, inhaled epoprosternol, inhaled PGE1 and oral such as endothelin receptor antagonists is permitted
•Note: it is unlikely to be on oral pulmonary vasodilators early in the course of CDH)
• ongoing therapy with parenteral (intravenous or subcutaneous) pulmonary vasodilators such as IV/SQ prostacyclin analogs (Epoprostenol
•Flolan or Treprostinil
•Remodulin or PGE1
•Alprostadil) or IV phosphodiesterase 5 inhibitors (sildenafil
•Revatio) at the time of randomization. In addition, initiation of therapy with these two classes of parenteral medications during the first 24 hours of study drug initiation is not permitted and will be considered a protocol deviation. The risk of systemic hypotension is high during the first 24 hours of study-drug (milrinone) infusion and hence parenteral administration of other pulmonary vasodilators is avoided to minimize risk of hypotension.
• Subjects already on ECMO or patients who are being actively considered for ECMO by the neonatal or surgical team
• attending (neonatal, critical care or surgical) refusal for participation in the trial (including concern about presence of hemodynamic instability)
Drug: Milrinone, Drug: Placebo (5% Dextrose)
Congenital Diaphragmatic Hernia, Persistent Pulmonary Hypertension of the Newborn, Hypoxemic Respiratory Failure, Pulmonary Hypoplasia, Cardiovascular, Other Respiratory and Intrathoracic Organs
CDH, PPHN, HRF
Parkland Health & Hospital System
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The Role of Aldosterone on Augmented Exercise Pressor Reflex in Hypertension

Hypertensive patients often show an exaggerated rise in blood pressure during exercise through overactivity of the exercise pressor reflex. An increasing body of evidence suggests a role for aldosterone in augmenting the exercise pressor reflex in hypertensive humans. We hypothesize that this effect of aldosterone is mediated by its direct action on the central nervous system and that administration of mineralocorticoid receptor antagonists constitute an effective treatment for EPR overactivity in hypertension, independent of reductions in resting BP.
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Wanpen Vongpatanasin
17620
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT01996449
STU 072012-066
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Inclusion Criteria:

• Experiments will be performed on 3 groups of nondiabetic human subjects:
• 1) stage I (140-159/90-99 mmHg) subjects with essential hypertension.
• 2) stage I hypertensive subjects with primary aldosteronism
• 3) normotensive controls.
Exclusion Criteria:

• 1) Any evidence of cardiopulmonary disease, left ventricular hypertrophy or systolic dysfunction by echocardiography.
• 2) Blood pressure averaging ≥160/100 mmHg
• 3) Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2
• 4) Diabetes mellitus or other systemic illness
• 5) Pregnancy
• 6) Hypersensitivity to nitroprusside, phenylephrine, amlodipine or eplerenone
• 7) Any history of substance abuse or current cigarette use
• 8) Any history of psychiatric illness
• 9) History of malignancy
Drug: Eplerenone, Drug: Amlodipine, Procedure: Microneurography, Procedure: Rhythmic handgrip exercise, Procedure: Sustained hand grip, Procedure: Forearm blood flow, Procedure: Arm cycling exercise, Procedure: Cold Pressor test
Hypertension, Other, Heart
Hypertension, blood pressure, Aldosterone, Eplerenone, Amlodipine, Primary aldosteronism, Exercise pressor reflex, handgrip exercise, passive arm cycling, active arm cycling
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Preventing Hypertension and Sympathetic Overactivation by Targeting Phosphate

An increasing number of studies have indicated that most fast food and common grocery items, contain large amount of inorganic phosphate-based food additives , which are highly absorbable. The long-term cardiovascular consequences of a high phosphate diet are unknown but the existing database implicates phosphate excess as an independent risk factor for cardiovascular events in individuals with and without chronic kidney diseases (CKD). High phosphate consumption clearly induces BP elevation in rats with normal kidneys. However, the mechanisms underlying phosphate-induced hypertension and the relevance of these rodent studies to human hypertension have not been determined. We seek to investigate the role of high phosphate diet in human hypertension and assess the effect of high phosphate diet on muscle sympathetic nerve activity and the exercise pressor reflex.
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Wanpen Vongpatanasin
17620
All
18 Years to 80 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03234361
STU 012017-052
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Inclusion Criteria:
(answer must be yes to all to enter trial; check yes or no) º ≥ 18 years of age º Stage 1 Prehypertension (office BP 120-129/80-84 mmHg and normal ABPM <130/80)
Exclusion Criteria:
(answer must be no to all to enter trial) º Diabetes mellitus or other systemic disease º Cardiopulmonary disease º Treatment with antihypertensive medications º eGFR< 60 ml/min/1.73m2 º Pregnancy º Hypersensitivity to nitroprusside or phenylephrine º Psychiatric illness º H/o substance abuse or current smoker º H/o malignancy º Serum Phos <2.4 mg/dL or >4.5 mg/dL
Dietary Supplement: High Phosphate Phase, Dietary Supplement: Low Phosphate Phase
Hypertension, Cardiovascular
Hypertension, High phosphorus diet, FGF 23, 24 hour ambulatory blood pressure, Muscle sympathetic nerve
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Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score (TEAMMATE)

The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years. Half of the participants will receive everolimus and low-dose tacrolimus and the other half will receive tacrolimus and mycophenolate mofetil. The trial will determine which treatment is better at reducing the cumulative risk of coronary artery vasculopathy, chronic kidney disease and biopsy proven-acute cellular rejection without an increase in graft loss due to all causes (e.g. infection, PTLD, antibody mediated rejection).
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David Sutcliffe
53153
All
up to 21 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03386539
STU 122017-025
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Inclusion Criteria:
1. Orthotopic heart transplantation 2. Age < 21 years at time of transplant 3. Stable immunosuppression at the time of randomization with no contraindication to everolimus, tacrolimus, or mycophenolate mofetil 4. Planned follow-up at a study site for the 30 month duration of the study. 5. Subject or legal adult representative capable of providing informed consent (in general, assent will be sought for children aged 12 years or older).
Exclusion Criteria:
1. Multi-organ transplant (e.g. heart-lung or heart-liver). 2. Known hypersensitivity to everolimus, sirolimus, tacrolimus or mycophenolate mofetil (MMF), or to components of the drug products. 3. Patients on maintenance corticosteroid therapy exceeding a dose equivalent of prednisone 0.1 mg/kg/day at randomization. 4. High-risk for rejection defined as active rejection, recurrent (≥ 2 episodes of grade 2R rejection) cellular rejection, recurrent rejection (≥ 2 episodes of any grade) with hemodynamic compromise, steroid-resistant rejection or unresolved antibody-mediated rejection during the first 6 months post-heart transplant 5. Graft dysfunction (LVEF <40% or wedge pressure >22 mmHg or cardiac index <2.2 L/min/m2) 6. Stage 4 or 5 CKD (eGFR <30 ml/min/1.73 m2) or moderate proteinuria (urine protein to urine creatinine ratio >0.5 mg/mg). 7. Active infection requiring hospitalization or treatment dose medical therapy. 8. Patients with ongoing wound healing problems, clinically significant wound infection requiring continued therapy or other severe surgical complication in the opinion of the Site Principal Investigator. 9. Fasting Serum Cholesterol ≥300 mg/dL OR greater than or equal to 7.75 mmol/L, AND fasting triglycerides ≥2.5x the upper limit of normal (ULN). Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication, and reduction of serum cholesterol and triglyceride levels to below exclusion ranges is confirmed. 10. Uncontrolled diabetes mellitus. 11. Diagnosis of post-transplant lymphoproliferative disorder (PTLD) during the first 6 months post-heart transplant. 12. History of non-adherence to medical regimens. 13. Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) and cannot discontinue the treatment 14. Patients who are pregnant or breast-feeding or intend to get pregnant during the study period.
Drug: Everolimus, Drug: Tacrolimus, Drug: Mycophenolate Mofetil
Post-transplant Lymphoproliferative Disorder, Chronic Kidney Diseases, Pediatric Heart Transplantation, Immunosuppression, Cardiac Allograft Vasculopathy, Heart Transplant Failure and Rejection, Heart Transplant Infection
heart transplantation, children, everolimus, tacrolimus, mycophenolate mofetil, randomized clinical trial
Children’s Health
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RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers (RelayPro-A)

Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.
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Carlos Timaran
68421
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02818972
STU 112016-073
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Inclusion Criteria:

• Subject must be ≥ 18 years of age
• Subject has specified disease in his/her descending thoracic aorta.
• Subject have anatomical compliance for the device specified for both access vessels and treatment area.
• Subject must be willing to comply with the follow-up evaluation schedule.
• Subject (or Legally Authorized Representative) agrees an Informed Consent Form prior to treatment.
Exclusion Criteria:

• Subject has specified disease of the thoracic aorta which is not included in the trial, for example: aortic dissection, intramural hematoma, traumatic injury or transection, aortic false aneurysm, ruptured aneurysm.
• Subject anatomy with significant stenosis, calcification, thrombus or tortuosity.
• Subjects with specified compromised circulation.
• Subjects with specified prior procedures.
• Subjects with allergy to contrast media or device components.
• Subjects with disease, for example: suspected connective tissue disorder, specified coagulation disorders, specified coronary artery disease, severe congestive heart failure, stroke and/or Myocardial Infarction (MI) as specified, specified pulmonary disease, specified renal failure.
• Subjects that are pregnant or planning to become pregnant during the course of the study.
Device: RelayPro
Aortic Aneurysm, Thoracic, Cardiovascular
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Sleep for Stroke Management and Recovery Trial (Sleep SMART)

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.
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Mehari Gebreyohanns
141046
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03812653
STU-2019-0861
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Inclusion Criteria:
1. TIA with ABCD2 ≥4 or ischemic stroke, within the prior 14 days.
Exclusion Criteria:
1. pre-event inability to perform all of own basic ADLs 2. unable to obtain informed consent from subject or legally authorized representative 3. incarcerated 4. known pregnancy 5. current mechanical ventilation (can enroll later if this resolves) or tracheostomy 6. current use of positive airway pressure, or use within one month prior to stroke 7. anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible 8. severe bullous lung disease 9. history of prior spontaneous pneumothorax or current pneumothorax 10. hypotension requiring current treatment with pressors (can enroll later if this resolves) 11. other specific medical circumstances that conceivably, in the opinion of the site PI, could render the patient at risk of harm from use of CPAP 12. massive epistaxis or previous history of massive epistaxis 13. cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus 14. recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure 15. current receipt of oxygen supplementation >4 liters per minute 16. current contact, droplet, respiratory/airborne precautions
Device: CPAP
Stroke, Ischemic Stroke, Sleep Apnea, Sleep Apnea, Obstructive, TIA, CPAP, Telemedicine, Home Sleep Apnea Test, Randomized Clinical Trial, Multicenter Trial
UT Southwestern
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Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy (ATTRibute-CM)

Phase 3 efficacy and safety study to evaluate acoramidis (AG10) 800 mg administered orally twice a day compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
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
NCT03860935
STU-2018-0350
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Inclusion Criteria:

• Have an established diagnosis of ATTR-CM with either wild-type TTR or variant TTR genotype
• Have a history of heart failure evidenced by at least one prior hospitalization for heart failure or clinical evidence of heart failure without prior heart failure hospitalization manifested by signs or symptoms of volume overload or elevated intracardiac pressures or heart failure symptoms that required or require ongoing treatment with a diuretic.
• New York Heart Association (NYHA) Class I-III symptoms due to ATTR cardiomyopathy.
• On stable doses of cardiovascular medical therapy
• Completed ≥150 m on the 6MWT on 2 tests that are within 15% of total distance walked prior to randomization
• Biomarkers of myocardial wall stress, NT-proBNP level ≥300 pg/mL at screening
• Have left ventricular wall (interventricular septum or left ventricular posterior wall) thickness ≥12 mm
Exclusion Criteria:

• Had acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke or transient ischemic attack within 90 days prior to screening
• Has hemodynamic instability
• Likely to undergo heart transplantation within a year of screening
• Confirmed diagnosis of primary (light chain) amyloidosis
• Biomarkers of myocardial wall stress, NT-proBNP level ≥8500 pg/mL at screening
• Measure of kidney function, eGFR by MDRD formula <15 mL/min/1.73 m2
• Current treatment with marketed drug products and other investigational agents for the treatment of ATTR-CM
• Current treatment with calcium channel blockers with conduction system effects (e.g. verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digitalis will only be allowed if required for management of atrial fibrillation with rapid ventricular response
Drug: acoramidis, Drug: Placebo Oral Tablet
Heart Diseases, Amyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis, Cardiomyopathies, Cardiovascular
Amyloidosis, ATTR-CM, Transthyretin, Amyloid, TTR
UT Southwestern
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GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms (TAMBE)

This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Carlos Timaran
68421
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02528500
STU-2019-0510
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Inclusion Criteria:
1. Aortic aneurysm involving the visceral vessels requiring treatment 2. Adequate access for TAMBE Device components 3. Appropriate aortic anatomy to receive the TAMBE Device 4. Age ≥ 18 years at the time of informed consent signature 5. Male or infertile female 6. The patient is considered high risk for open repair as deemed by the treating physician 7. Capable of complying with protocol requirements, including follow-up 8. An Informed Consent Form signed by Subject or legal representative Note: Additional Inclusion Criteria may apply
Exclusion Criteria:
1. Prior aortic surgery 2. Ruptured or leaking aortic aneurysm 3. Aneurysmal dilatation due to chronic aortic dissection 4. Infected aorta 5. Mycotic aneurysm 6. Life expectancy <2 years 7. Myocardial infarction or stroke within 6 weeks of treatment 8. Systemic infection which may increase risk of endovascular graft infection 9. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome 10. Participation in another drug or medical device study within 1 year of study enrollment 11. History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment 12. Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access 13. Known sensitivities or allergies to the device materials 14. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin 15. Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta 16. Renal Insufficiency Note: Additional Exclusion Criteria may apply
Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
Thoracoabdominal Aortic Aneurysm, Cardiovascular
UT Southwestern
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Hyperinflation Respiratory Therapies in Cardiac Surgery Patients

The purpose of this prospective randomized clinical trial is to evaluate three different types of hyperinflation respiratory therapies, Intermittent Positive Pressure Breathing (IPPB), Intermittent positive end expiratory pressure (EzPAP), Metaneb. Investigators will examine which hyperinflation therapy provides better lung expansion and may improve lung recovery after surgery.
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studyfinder@utsouthwestern.edu
Jaffer Odeh
136385
All
18 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04164173
STU-2019-1242
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Inclusion Criteria:
1. Age 18 years and older 2. Admitted to Cardiovascular ICU (CVICU) after coronary artery bypass grafting (CABG), isolated valve repair/replacement, or CABG + valve repair/replacement 3. Cardiac surgery performed via median sternotomy
Exclusion Criteria:
1. BMI>40 2. Refusal to be consented 3. Prior or current lung transplant patients
Device: EzPAP, Device: Metaneb, Device: Intermittent Positive Pressure Breathing (IPPB)
Pulmonary Disease, Postoperative Complications, Cardiovascular
UT Southwestern
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Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults (PREVENTABLE)

PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Craig Rubin
16278
All
75 Years and over
Phase 4
This study is also accepting healthy volunteers
NCT04262206
STU-2020-0579
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Inclusion Criteria:

• Community-dwelling adults
• Age ≥75 years
• English or Spanish as primary language
Exclusion Criteria:

• Clinically evident cardiovascular disease defined as prior myocardial Infarction (MI), prior stroke, prior revascularization procedure, or a secondary prevention indication for a statin (clinician determined)
• Hospitalization for a primary diagnosis of heart failure in the prior 12 months (Note: History of heart failure in the absence of recent hospitalization or clinically evident cardiovascular disease is not an exclusion)
• Dementia (clinically evident or previously diagnosed)
• Dependence in any Katz Basic Activities of Daily Living [ADL] (with the exception of urinary or bowel continence)
• Severe hearing impairment (preventing phone follow up)
• Unable to talk (preventing phone follow up)
• Severe visual impairment (preventing cognitive testing)
• Statin use in the past year or for longer than 5 years previously (participant reported)
• Ineligible to take atorvastatin 40 mg (clinician determined)
• Documented intolerance to statins
• Active Liver Disease
• Long-term use of daily colchicine, verapamil at any dose, or diltiazem at a dose >240mg/day.
Drug: Atorvastatin 40 Mg Oral Tablet, Drug: Placebo oral tablet
Dementia, Cardiovascular Diseases, Unknown Sites, Cognitive Impairment, Mild
statin, older adults
Parkland Health & Hospital System
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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.
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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, 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). 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
Call 214-648-5005
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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