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72 Study Matches

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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Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia (STRENGTH)

The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached
Call 214-648-5005
studyfinder@utsouthwestern.edu
Parag Joshi
164267
All
18 Years to 99 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02104817
STU 112014-012
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Inclusion Criteria:
1. Men or women, ≥18 years of age. 2. Patient must be on a stable diet and statin* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria: 1. LDL-C <100 mg/dL 2. TG level ≥180 and <500 mg/dL and HDL-C <42 mg/dL for men or HDL-C <47 mg/dL for women 3. Patient is at high risk for a future cardiovascular event if at least one of the following criteria (3a, 3b or 3c)* is present via patient history, physical exam, or medical records at the time of screening: 1. Any atherosclerotic CVD as defined in protocol. 2. History of diabetes mellitus (type 1 or 2) and ≥40 years of age for men and ≥50 years of age for women, plus one of the risk factors defined in protocol. 3. Male patients >50 years of age or females >60 years of age, with at least one of the risk factors defined in protocol. Key
Exclusion Criteria:
1. Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil. 2.Use of fibrates, bile acid sequestrants, or niacin or its analogues (>250 mg/day) within 4 weeks prior to Visit 2. 3.Statin naïve at Visit 1.
Drug: Epanova® (omega-3 carboxylic acids), Drug: corn oil control
Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
omega-3 carboxylic acid
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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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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
Cardiac Arrest, Cardiopulmonary Arrest, Pediatric Cardiac Arrest, VABS, Vineland Adaptive Behavior Scale, POPC/PCPC, hypoxic-ischemic encephalopathy
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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.
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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
Pediatric Heart failure,, systemic left ventricle,, reduced ejection fraction
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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.
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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
Dementia, Alzheimer's Disease, Blood Pressure, Cognitive Function, Magnetic Resonance Imaging
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Effect of Carvedilol on Exercise Performance in Fontan Patients

This study evaluates the effect of carvedilol in patients who have undergone a Fontan heart operation. All participants will receive carvedilol and placebo for 12 weeks. Exercise tests will be performed at the end of each 12 week period.
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Ryan Butts
169606
All
10 Years to 35 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT02946892
STU 062016-101
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Inclusion Criteria:
1. Informed consent of parent(s) or legal guardian; informed consent or assent of subject as applicable. 2. Male or female children between the ages of 10 and 35 years with congenital heart disease that has been palliated with a Fontan circulation. 3. Ability of perform a maximal exercise test as defined by a respiratory exchange ratio (RER) greater than 1.0 at the time of maximal exercise
Exclusion Criteria:
1. The use of beta blockers within 2 months of randomization 2. Patients actively listed for transplantation at time of entry into the study or anticipated to undergo heart transplantation, interventional catheterization, or corrective cardiac surgery during the 7 months following entry into the study 3. Sustained or symptomatic ventricular dysrhythmias uncontrolled by drug therapy or the use of an implantable defibrillator, and/or significant cardiac conduction defects, e.g., 2nd degree or 3rd degree AV block, or sick sinus syndrome, unless a functioning pacemaker is in place 4. Uncorrected obstructive or severe regurgitant valve disease, nondilated cardiomyopathy, or significant systemic ventricular outflow obstruction 5. Known renovascular hypertension or evidence of pulmonary hypertension (pulmonary vascular resistance > 6 Wood units) unresponsive to vasodilator agents such as oxygen, nitroprusside, or nitric oxide 6. History or current clinical evidence of moderate-to-severe fixed obstructive pulmonary disease or severe reactive airway diseases (e.g., asthma) requiring hospitalization within the past 2 years or patient currently using long-term inhaled bronchodilators 7. Renal, hepatic, gastrointestinal, or biliary disorder that could impair absorption, metabolism or excretion of orally administered medication 8. Concurrent terminal illness or other severe disease (e.g., active neoplasm) or other significant laboratory value(s) which, in the opinion of the investigator, could preclude participation or survival 9. Endocrine disorders such as primary aldosteronism, pheochromocytoma, hyper- or hypothyroidism, insulin-dependent diabetes mellitus 10. Unwillingness or inability to cooperate, or for the parents or guardians to give consent, or for the child to give assent, or any condition of sufficient severity to impair cooperation in the study 11. Pregnancy or possible pregnancy at time of randomization, or female of child bearing potential who are lactating, or sexually active and not taking adequate contraceptive precautions (e.g., intrauterine device or oral contraceptives for 3 months prior to entry into the study) 12. Use of an investigational drug within 30 days of randomization, or within 5 half-lives of the investigational drug (the longer period will apply) 13. History of drug sensitivity or allergic reaction to alpha-blockers or ß-blockers 14. Use of any of the following medications within two weeks of randomization: MAO inhibitors, Calcium channel blockers, alpha blockers, beta blockers, disopyramide, flecainide, encainide, moricizine, propafenone, sotalol, or beta adrenergic agonists 15. Hospital admission for protein losing enteropathy or plastic bronchitis within 3 months of randomization 16. Active and/or chronic protein losing enteropathy or plastic bronchitis (on inhaled medication to control the plastic bronchitis). 17. Hypoalbuminemia defined as serum albumin <2.0g/dL 18. Renal dysfunction defined as serum creatinine >2.0mg/dL 19. Hepatic dysfunction defined as serum AST and/or ALT> 3 times upper limit of normal (approximately 120 IU/L however, will vary depending on age), 20. Significant anemia or polycythemia defined as hemoglobin >18gm/dL or hemoglobin <7gm/dL 21. Severely elevated serum BNP defined as BNP>300pg/ml
Drug: Carvedilol, Drug: Placebo
Single Ventricle, Fontan
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Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization

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Lawrence Lavery
116716
All
45 Years to 99 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03006770
STU 092017-051
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Inclusion Criteria:
1. Adult male or female subjects between ages 45-99 years of age. 2. CLI, with minor tissue loss up to the ankle level (Rutherford Category 5) 3. Ankle pressure (AP) ≤70 mmHg or TP ≤50 mmHg in the index leg. (If a subject has ABI >1.4 and TP is not measureable, inclusion may be based on TcPO2 ≤30 mmHg) 4. Subject unsuitable for revascularization (by any method) in the index leg. 5. Ischemic lesions in the index leg stable for at least 2 weeks. 6. Ischemic ulcers in the index leg without tendon or bone exposure (unless secondary to a minor amputation). 7. Under treatment for cardiovascular risk factors: hypertension, hyperlipidemia, diabetes, in accordance with applicable guidelines. Concomitant therapy with a statin and an anti-platelet agent for at least 2 weeks prior to randomization. 8. Women of childbearing potential must have a negative serum pregnancy test at screening and must be willing to use at least one highly effective birth control method throughout the study. 9. Signed informed consent form.
Exclusion Criteria:
1. Non-atherosclerotic PAD (e.g. Buerger's disease). 2. CLI with major tissue loss (Rutherford Category 6) in either leg. 3. Evidence of active infection (e.g., cellulitis, osteomyelitis). 4. Subject having undergone surgical revascularization or major amputation less than 1 month prior to screening, or endovascular revascularization or minor amputation less than 2 weeks prior to screening. 5. Planned or potential need for major/minor amputation or any revascularization within 1 month of study entry upon investigator's judgment. 6. Aorto-iliac stenosis or common femoral artery stenosis ≥70%, or otherwise suspicion of inadequate inflow to the leg. 7. Life expectancy of less than 6 months. 8. Stroke or acute myocardial infarction/unstable angina within 3 months prior to screening. 9. Severe congestive heart failure symptoms (New York Heart Association [NYHA] Stage IV). 10. Uncontrolled severe hypertension. 11. Diabetes mellitus with HbA1c >10%. 12. Current or history of proliferative retinopathy. 13. Known Hepatitis B virus or Hepatitis C virus or acquired immunodeficiency syndrome (AIDS) infections. 14. Subjects with international normalized ratio (INR) >2.5. 15. Subject on renal replacement therapy or with eGFR <15 mL/min/1.73m2. 16. Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending another investigational device or drug trial(s), unless in long-term follow-up phase. 17. Use of hyperbaric oxygen therapy, prostanoids, spinal cord stimulation, lumbar sympathectomy, wound dressing containing cells or growth factors, or topical platelet derived growth factor. 18. Known allergies to any of the following: DMSO, human serum albumin, bovine serum albumin. 19. History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with IV steroids/epinephrine. 20. Pulmonary disease requiring supplemental oxygen treatment on a daily basis. 21. Active malignancy or history of malignancy within 5 years prior to study entry. 22. In the opinion of the investigator, the subject is unsuitable for participating in the study. 23. Inability to understand and provide an informed consent.
Biological: PLX-PAD, Biological: Placebo
Critical Limb Ischemia (CLI)
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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
Hypertension, blood pressure, Aldosterone, Eplerenone, Amlodipine, Primary aldosteronism, Exercise pressor reflex, handgrip exercise, passive arm cycling, active arm cycling
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Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients

This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant who are at high risk or very high risk of developing VOD.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Tiffany Simms-Waldrip
119738
All
1 Month and over
Phase 3
This study is NOT accepting healthy volunteers
NCT02851407
STU 092016-093
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Inclusion Criteria:
1. Patient must be above the age of 1 month as of the start date of study treatment. 2. Patient must be scheduled to undergo allogeneic hematopoietic stem cell transplant (HSCT) (adults or pediatric patients) or autologous HSCT (pediatric patients only) and be at high risk or very high risk of developing veno-occlusive disease (VOD). 3. Female patients (and female partners of male patients) of childbearing potential who are sexually active must agree to use a highly effective method of contraception with their partners during exposure to defibrotide and for 1 week after the last dose of defibrotide. 4. Adult patients must be able to understand and sign a written informed consent. For minor patients, the parent/legal guardian or representative must be able to understand and sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Exclusion Criteria:
1. Patient has hemodynamic instability within 24 hours before the start of study treatment. 2. Patient has acute bleeding that is clinically significant within 24 hours before the start of study treatment. 3. Patient used any medication that increases the risk of bleeding within 24 hours before the start of study treatment. 4. Patient is using or plans to use an investigational agent for the prevention or treatment of VOD. 5. Patient, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study. 6. Patient or parent/legal guardian or representative has a psychiatric illness that would prevent the patient or parent/legal guardian or representative from giving informed consent and/or assent. 7. Patient has a serious active disease or co-morbid medical condition, as judged by the investigator, which would interfere with the conduct of this study. 8. Patient is pregnant or lactating and does not agree to stop breastfeeding. 9. Patient has a known history of hypersensitivity to defibrotide or any of the excipients. 10. Patient or parent/legal guardian or representative lacks the full mental capacity to understand and sign a written informed consent. 11. Patient is receiving or plans to receive other investigational therapy during study.
Drug: Defibrotide, Other: Best Supportive Care
Veno-occlusive Disease
stem cell transplant, hematopoietic stem cell transplant (HSCT), veno-occlusive disease (VOD), sinosoidial obstruction syndrome (SOS)
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Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer (CANVAS)

The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The intervention strategy is Direct Oral AntiCoagulants (DOAC) therapy with edoxaban, apixaban, rivaroxaban, or dabigatran. The comparator is low molecular weight heparin (LMWH) alone or with warfarin. The information gained will empower cancer patients and physicians to make more informed choices about anticoagulation strategies to manage VTE.
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canceranswerline@utsouthwestern.edu
Cynthia Rutherford
16307
All
21 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02744092
STU 032017-071
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Inclusion Criteria:

• Diagnosis of advanced solid tumor cancer, lymphoma, or myeloma (no time restrictions or limitations) -OR- diagnosis of early stage solid tumor cancer, lymphoma, or myeloma <= 12 months prior to study enrollment
• Diagnosis of VTE <= 30 days prior to study enrollment for which potential benefits of anticoagulation therapy to prevent recurrence of VTE are felt by the treating physician to exceed the potential harms
• Any anticoagulation drug/strategy may be used to treat the index VTE; protocol treatment will begin <= 30days after the index VTE diagnosis date
• Treating physician intends to put participant on anticoagulation therapy for at least three months.
• Age >= 21 years
• Platelet count is >= 50,000/mm^3 (<= 7 days prior to enrollment)
• CrCl (Creatinine Clearance) is >= 15 ml/min (<= 7 days prior to enrollment)
Exclusion Criteria:

• Diagnosis of acute leukemia
• Has ever received or is scheduled to receive an Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
• Patients who have ever received an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) ARE eligible.
• Patients who are scheduled to receive an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) are NOT eligible
• Ongoing, clinically significant bleeding (CTCAE grade 3 or 4)
• Ongoing therapy with a P-gp inhibitor (e.g., nelfinavir, indinavir, or saquinavir-protease inhibitors for HIV) as these drugs interact with the factor Xa inhibitors
• Therapy with any azole antifungals (e.g., itraconazole, ketaconazole, voriconazole) at the time of enrollment
Drug: Rivaroxaban, Drug: Apixaban, Drug: Edoxaban, Drug: Dabigatran, Drug: Warfarin, Drug: Dalteparin, Drug: Enoxaparin, Drug: Fondaparinux
Cancer, Venous Thromboembolism, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Blood Clot
Rivaroxaban (Xarelto), Apixaban (Eliquis), Edoxaban (Savaysa), Dabigatran (Pradaxa), Warfarin (Coumadin), Low molecular weight heparin (LMWH)
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Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient

This is a single center prospective longitudinal exercise training study and will enroll approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical activity level between the ages of 10-40 years. Participants will undergo an MRI of the Fontan circulation. This will include imaging of the heart, lung and liver. This will include specific imaging for tissue characterization and assessment of myocardial fibrosis, liver fibrosis and disproportionate pulmonary blood flow. The investigators will then draw blood (approximately 10 ml) for assessment of serum biomarkers and circulating microRNAs of interest. The participants will undergo exercise testing and will then start a 3-6 month long cardiac rehabilitation program. After the 3-6 month study period the participants will return back for a follow up and repeat all the testing completed at enrollement.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Maria Bano
163353
All
10 Years to 40 Years old
N/A
This study is also accepting healthy volunteers
NCT03263312
STU 122016-037
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Inclusion Criteria:

• Presence of a congenital heart defect that leads to single ventricle physiology
• Previously performed TCPA surgery
• Current age 10 years to 40 years
• Informed consent
Exclusion Criteria:

• History of exercise intolerance (peak VO2<12ml/kg/min)
• Unstable arrhythmia at the time of screening
• Listed or being evaluated for heart transplantation
• Pregnancy or breast feeding
• Patient with pacemaker, AV block other than 1st degree block, sick sinus syndrome or other arrhythmia that may influence ability to perform exercise test or magnetic resonance imaging
Behavioral: Exercise
Single-ventricle, Myocardial Fibrosis
myocardial fibrosis, exercise training, Fontan
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Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score (TEAMMATE)

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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
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RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers (RelayPro-A)

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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
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Sildenafil Treatment for Mild TBI

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Joshua Gatson
104389
Male
18 Years to 35 Years old
Phase 2
This study is also accepting healthy volunteers
NCT03598140
STU 032018-063
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Inclusion Criteria:
For Athletes 1. Age 18-35 2. Male or female professional boxers/MMA fighters 3. Ability to undergo MR imaging procedures 4. At least one of the following: 1. Knockout (KO)/Technical Knockout (TKO) scored by fight referee. 2. Greater than 25 blows to the head. 5. Significant post-concussive symptoms (Symptom Score > 1 on at least 3 items from the Rivermead Post-Concussion Questionnaire) For Controls 1. Age 18-35 2. Male of female who do not participate in contact sports 3. Screen negative for mild TBI (mTBI) using Ohio State TBI Identification
Exclusion Criteria:
1. Contraindication to sildenafil which includes the following: 1. Current use of organic nitrate vasodilators 2. Use of ritonavir (HIV-protease inhibitor) 3. Current use of erythromycin, ketoconazole, or itraconazole 4. Current use of cimetidine 5. Current resting hypotension (BP < 90/50 mm Hg) 6. Current severe renal insufficiency (Creatinine Clearance < 30 milliliters/minute) 7. Current hepatic cirrhosis 8. Current cardiac failure or coronary artery disease causing unstable angina 9. Retinitis pigmentosa 10. Known hypersensitivity or allergy to sildenafil of any of its components 2. Daily therapy with a PDE5 inhibitor within the past 2 months 3. Immediate hospitalization for severe concussion 4. History of neurological or psychiatric disorder not related to TBI 5. Known inclusion in another interventional clinical trial 6. Subjects with metal implants that would interfere with the MR imaging procedures 7. Sickle cell disease 8. History of priapism
Drug: Sildenafil Citrate, Drug: Placebo oral capsule
Vascular System Injuries, Concussion, Brain, Post-Concussion Syndrome
Sildenafil, Concussion, CBF, CVR
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Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy (EXPLORER-HCM)

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Aslan Turer
110995
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03470545
STU 042018-093
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Key
Inclusion Criteria:

• Age 18 and greater, body weight ≥ 45kg
• Has adequate acoustic windows to enable accurate transthoracic echocardiograms (TTEs)
• Diagnosed with oHCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines and satisfy both criteria:
• Has documented left ventricular ejection fraction (LVEF) ≥55%
• NYHA Class II or III
• Has documented oxygen saturation at rest ≥90% at Screening
• Is able to perform an upright CPET and has a respiratory exchange ratio (RER) ≥1.0 at Screening per central reading
• LVOT gradient with Valsalva maneuver >=30 mmHg at Screening determined by echocardiography core lab Key
Exclusion Criteria:

• Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy
• History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to Screening
• History of resuscitated sudden cardiac arrest (at any time) or known history of appropriate implantable cardioverter defibrillator (ICD) discharge for life-threatening ventricular arrhythmia within 6 months prior to Screening
• Paroxysmal, intermittent atrial fibrillation with atrial fibrillation present at Screening
• Persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or not adequately rate controlled within 6 months prior to Screening
• Treatment (within 14 days prior to Screening) or planned treatment during the study with disopyramide or ranolazine
• Treatment (within 14 days prior to Screening) or planned treatment during the study with a combination of β-blockers and calcium channel blockers
• LVOT gradient with Valsalva maneuver <30 mmHg at Screening
• Has been successfully treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation [ASA]) within 6 months prior to Screening or plans to have either of these treatments during the study
• ICD placement within 6 months prior to Screening or planned ICD placement during the study
• Has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion
• Prior treatment with cardiotoxic agents such as doxorubicin or similar
Drug: mavacamten, Drug: Placebo
Obstructive Hypertrophic Cardiomyopathy
Symptomatic, left ventricular outflow tract gradient
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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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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
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PRESERVE-Zenith® Iliac Branch System Clinical Study

The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.
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Carlos Timaran
68421
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT01208415
STU 122013-028
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Inclusion Criteria:

• An aortoiliac or iliac aneurysm of appropriate size
• Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery
Exclusion Criteria:

• Less than 18 years of age
• Inability or refusal to give informed consent
• Disease considerations that would compromise patient safety or study outcomes
• Unsuitable arterial anatomy
Device: Endovascular repair for aortoiliac or iliac aneurysms.
Aorto-iliac Aneurysms, Iliac Aneurysms
Zenith aortoiliac aneurysm, iliac aneurysm, branch, connections, endovascular graft, graft-iliac bifurcation, Aneurysm, Vascular Diseases, Cardiovascular Diseases
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Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term (ADAPTABLE)

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Sandeep Das
60800
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02697916
STU 052016-010
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Inclusion Criteria:

• Known atherosclerotic cardiovascular disease (ASCVD), defined by a history of prior myocardial infarction, prior coronary angiography showing ≥75% stenosis of at least one epicardial coronary vessel, or prior coronary revascularization procedures (either PCI or CABG), or history of chronic heart disease, CAD, ASCVD
• Age ≥ 18 years
• No known safety concerns or side effects considered to be related to aspirin, including
• No history of significant allergy to aspirin such as anaphylaxis, urticaria, or significant gastrointestinal intolerances
• No history of significant GI bleed within the past 12 months
• Significant bleeding disorders that preclude the use of aspirin
• Access to the Internet. In the event that the CDRNs are notified that a cohort of patients without internet access can be included, then patient agreement will be obtained during the consent process to provide follow-up information by telephone contact with the DCRI Call Center.
• Not currently treated with an oral anticoagulant
•either warfarin or a novel anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban)
•and not planned to be treated in the future with an oral anticoagulant for existing indications such as atrial fibrillation, deep venous thrombosis, or pulmonary embolism.
• Not currently treated with ticagrelor and not planned to be treated in the future with ticagrelor.
• Female patients who are not pregnant or nursing an infant
• Estimated risk of a major cardiovascular event (MACE) > 8% over next 3 years as defined by the presence of at least one or more of the following enrichment factors:
• Age > 65 years
• Serum creatinine > 1.5 mg/dL
• Diabetes mellitus (Type 1 or Type 2)
• 3-vessel coronary artery disease
• Cerebrovascular disease and/or peripheral arterial disease
• Left ventricular ejection fraction (LVEF) < 50%
• Current cigarette smoker
• Chronic systolic or diastolic heart failure
• SBP > 140 (within past 12 mos)
• LDL > 130 (within past 12 mos)
Exclusion Criteria:

• There will be no exclusions for any upper age limit, comorbid conditions, or concomitant medications other than oral anticoagulants and ticagrelor that are used at the time of randomization, or are planned to be used during the study follow-up.
• Patients and sites interested in participating must be part of the listed health systems collaborators.
Drug: aspirin
Atherosclerotic Cardiovascular Disease
aspirin, ACSD, PCORI
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Optimal Delay Time to Initiate Anticoagulation After Ischemic Stroke in Atrial Fibrillation (START)

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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
Stroke, Atrial Fibrillation, Anticoagulation, NOAC
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High Intensity Exercise for Increasing Fitness in Patients With Hypertrophic Cardiomyopathy

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Benjamin Levine
14262
All
18 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03335332
STU 072017-048
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Inclusion Criteria:

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

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

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Ryan Davies
175318
All
10 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02459054
STU 072015-057
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Inclusion Criteria (Primary Pediatric and Adult Arms):
• At imminent risk of death from biventricular heart failure
• Aged 10
•18 years (pediatric); 19
•75 years (adults) at time of implant
• With two functional atrioventricular (A-V) valves
• With Body Surface Area (BSA) of 1.2 through 1.85m2
• With adequate sternum to T10 distance OR Adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
Exclusion Criteria:

• Patients who are not cardiac transplant-eligible
• Cardiac transplant-eligible patients
• Who cannot be adequately anticoagulated on the TAH-t
• With insufficient space in the chest
• Who are on extracorporeal membrane oxygenation (ECMO) support > 3 days
• Patients who are being supported by an investigational device at the time of evaluation for a 50cc TAH-t
• Patients who have required cardiopulmonary resuscitation (CPR) for > 30 minutes within 14 days prior to proposed implant
• Patients who have experienced a stroke within 30 days prior to proposed implant
• Patients who are dialysis-dependent at time of proposed implant Inclusion Criteria, Secondary Arm (pediatric and adult patients)
• Not eligible for Primary Arm
• At imminent risk of death from biventricular heart failure
• With Body Surface Area (BSA) of 1.2 through 1.85m2
• With adequate sternum to T10 distance OR Adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments Exclusion Criteria, Secondary Arm:
• Patients who are not cardiac transplant-eligible
• Cardiac transplant-eligible patients
• Who cannot be adequately anticoagulated on the TAH-t
• With insufficient space in the chest
• Patients who are being supported by an investigational device at the time of evaluation for a 50cc TAH-t
Device: SynCardia 50cc temporary Total Artificial Heart (TAH-t)
Heart Failure, Right-Sided, Cardiac Failure, Heart Failure, Left-Sided
Artificial Heart, Biventricular Heart Failure, SynCardia
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Pumps for Kids, Infants, and Neonates (PumpKIN)

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Ryan Davies
175318
All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT02954497
STU 112017-032
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Inclusion Criteria All children with severe (Ross or New York Heart Association (NYHA) class IV) heart failure despite optimal medical therapy (INTERMACS profiles for pediatrics: Profiles 1 or 2) who require mechanical circulatory support and meet the following criteria: 1. Males and females within weight range: 8.0 Kg ≤ weight ≤ 30.0 Kg 2. Males and females within Body surface area (BSA) range: 0.4 m2 ≤ BSA ≤ 1.0 m2 3. Cardiac anatomy categories: 1. Standard Cardiac Anatomy: Two-ventricle circulation, including cardiomyopathy, repaired structural heart disease (e.g. anomalous left coronary artery from the pulmonary artery [ALCAPA], aortic stenosis) or acquired heart disease (e.g., myocarditis, Kawasaki disease) 2. Challenging Cardiac Anatomy: Any challenging cardiac anatomy (including but not limited to single ventricle heart disease, RCM, HCM3-5) that, in the opinion of the investigator with confirmation from the PumpKIN Executive Committee, is difficult to support with available (e.g. pulsatile) devices. 4. INTERMACS Profile 1 or 2 as evidenced by: 1. Inability to wean from extra-corporeal membrane oxygenation (ECMO) or other temporary circulatory support (TCS), OR 2. Inability to wean from mechanical ventilator support, OR 3. Inotrope-dependent, decompensated heart failure AND meet one or more of the following criteria within 48 hours prior to implant (unless otherwise noted) which is attributed to decompensated heart failure despite optimal medical therapy: i. Urine output <0.5 cc/kg/hour for 12hr within 48 hours ii. Creatinine level >2 times the upper limit of normal (ULN) for age iii. Alanine aminotransferase (ALT) or total bilirubin result >3 times the ULN for age (either qualifies the patient) iv. Mixed venous oxygen saturation (SvO2) <55% (or arteriovenous oxygen different >45%) in two repeated measurements v. Acidosis: Base excess >-5 in 2 or more measurements vi. Inability to tolerate appropriate enteral calories as prescribed by a registered dietician vii. Inability to ambulate freely to participate fully in age-appropriate activities of daily living (ADLs) and/or cardiac rehabilitation/physical therapy, OR 5. Potentially eligible (i.e., no medical or surgical contraindications) to be listed for cardiac transplant, United Network for Organ Sharing status 1A, or equivalent 6. Written consent of parent(s) or legally authorized representative (LAR) where appropriate. Exclusion Criteria To be eligible for this trial, the subjects must meet none of the following exclusion criteria at the time of enrollment or between the enrollment and device implant: 1. Known contraindication to systemic anticoagulation 2. Currently participating in an interventional trial whose protocol prevents effective application of the Jarvik 2015 device, potentially has an independent effect on trial endpoints, or otherwise interferes with execution of the PumpKIN protocol 3. Stable inotrope dependence (INTERMACS profile 3) 4. Single ventricle anatomy prior to stage II surgical palliation (i.e. prior to superior cavo-pulmonary anastomosis, also known as a Glenn or hemi-Fontan) or Fontan surgery 5. Presence of a mechanical heart valve 6. Unresolved malignancy 7. CPR with duration > 30 consecutive minutes within 48 hours prior to device implant or CPR with uncertain neurological status prior to device implant 8. Renal dysfunction that is severe or, in the opinion of the investigator, irreversible 9. Hepatic dysfunction that is severe or, in the opinion of the investigator, irreversible 10. Severe or irreversible pulmonary dysfunction 11. ECMO use for > 10 consecutive days 12. Unrepairable severe aortic insufficiency 13. Active, systemic infection unresponsive to antimicrobials therapy 14. Known cerebrovascular event within the past 30 days or uncertain neurological status 15. Severe right ventricular (RV) dysfunction or significant arrhythmia requiring treatment with an RV assist device (RVAD) (i.e., biventricular assist device) 16. Unmanageable bleeding per judgment of the investigator
Device: Surgical placement of the Jarvik 2015 VAD, Procedure: Surgical Placement of Jarvik 2015 VAD
Pediatric Heart Failure
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Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients

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

This is an investigator sponsored Investigational Device Exemption (IDE) aimed to assess the use of the Custom Made Device (CMD) to repair juxtarenal aneurysms, suprarenal and type IV thoracoabdominal aneurysms in standard risk patients having appropriate anatomy. This study is a prospective, single-center, non-randomized, single-arm study.
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Carlos Timaran
68421
All
18 Years to 90 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02266719
STU 072014-015
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General Inclusion Criteria A patient is deemed suitable for inclusion in the study if the patient has at least one the following: 1. Juxtarenal or suprarenal AAA and type I-IV thoracoabdominal aortic aneurysms with diameter ≥5.0 cm in diameter or 2 times the normal aortic diameter; 2. Aneurysm with history of growth ≥0.5 cm/year; 3. Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation. 4. Patients that are not eligible for treatment with commercially available endografts. General Exclusion Criteria A patient must be excluded from the clinical investigation if any of the following are true: 1. Age <18 years; 2. Life expectancy <2 years; 3. Pregnant, breast-feeding, or planning on becoming pregnant within 60 months; 4. Inability or refusal to give informed consent by the patient or a legally authorized representative; 5. Unwilling or unable to comply with the follow-up schedule; 6. Prior surgical or interventional procedure within 30 days of the anticipated date of the fenestrated procedure, with the exception of planned staged procedures to provide access for repair (e.g. staged iliac conduit, thoracic endovascular aortic aneurysm repair for proximal aneurysms), to facilitate the procedure by allowing open reparation of a target artery not amenable to revascularization with the investigational device, such us an internal iliac artery, subclavian artery or visceral artery with early bifurcation, tortuosity or occlusive disease preventing successful placement and alignment side stents, or to treat proximal aortic aneurysms. 7. Participation in another clinical or device trial, with the exception of observational studies or participation in another investigational endovascular endograft protocol or percutaneous aortic valve protocol, not encompassed by the IDE protocol (>30 days). 8. Patients with ruptured aortic aneurysm requiring urgent or emergent repair. Medical Exclusion Criteria Patients must be excluded from the study if any of the following conditions are true: 1. Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold 2. History of anaphylactic reaction to contrast material that cannot be adequately premedicated 3. Leaking or ruptured aneurysm associated with hypotension 4. Uncorrectable coagulopathy 5. Mycotic aneurysm or patients with evidence of active systemic infection. 6. History of connective tissue disorder (e.g. vascular Ehlers Danlos, Marfan's syndrome), with the exception of those patients who had prior open surgical aortic replacement or endovascular repair, where a surgical graft or an endograft would serve as landing zone for the investigational endograft. 7. Body habitus that would inhibit x-ray visualization of the aorta and its branches. Anatomical Exclusion Criteria Patient must be excluded from the study if any of the following is true: 1. Inadequate femoral or iliac access compatible with the requirements of the required delivery system. 2. Thoracic aortic aneurysms that extend into the arch, with the exception of those patients who had prior open surgical aortic replacement or endovascular repair, where a surgical graft or an endograft has been extended proximal and/or near the celiac artery (functional type IV) that would serve as landing zone for the investigational endograft. 3. Inability to perform a temporary or permanent open surgical or endovascular iliac conduit for patients with inadequate femoral/iliac access. 4. Absence of a landing aortic segment in the distal thoracic aorta above the diaphragmatic hiatus with: 1. A diameter measured outer to the outer wall greater than 38 mm or less than 19 mm; 2. Parallel aortic wall with >20% diameter change and with significant calcification and/or thrombus in the selected area of the seal zone. 5. Visceral anatomy not compatible with the investigational device due to excessive occlusive disease or small size not amenable to stent graft placement. 6. Unsuitable distal iliac arterial fixation site and anatomy: 1. Common iliac artery fixation site diameter, measured outer wall to outer wall on a section image (CT)< 8.0 mm with inability to perform surgical conduit. 2. Iliac artery diameter, measured outer wall to outer wall on a sectional image (CT) > 21 mm at distal fixation site, with inability to perform open internal iliac artery revascularization or iliac branch stent graft or custom iliac extension with fenestration. 3. Iliac artery distal fixation site <10 mm in length. 4. Inability to preserve at least one hypogastric artery. For patients in the type I-III TAAA cohort, the intended use criteria are the same for both the fenestrated/branched CMD vs the off-the-shelf device. The CMD will preferably be used, unless an urgent repair is indicated or the waiting period for design or manufacturing of the CMD is considered unacceptable.
Device: Fenestrated CMD, Device: Type I - III TAAA
Aortic Aneurysm, Abdominal
Aortic Aneurysm, Abdominal [C14.907.055.239.075]
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Active Preoperative Anemia Management in Patients Undergoing Cardiac Surgery (APART)

Anemia which is a decreased blood count or lower than normal hemoglobin (hgb), is a major health problem for patients having heart surgery. Hemoglobin is the part of our blood that carries oxygen from the lungs to the rest of the body. Anemia that is present before surgery, called preoperative anemia, is a risk factor for an increased chance of morbidity (illness) and/or mortality (death) after heart surgery. It is also an important indicator of blood transfusion necessity. Recent clinical research investigations done to study preoperative anemia suggest a blood transfusion can damage the immune system (the system that protects us from disease) which can lead to infection, organ dysfunction (especially of the heart, kidney, brain), prolonged hospital stays, as well as increased supplies, resources and cost in surgical patients. Comprehensive anemia management can reduce or eliminate the need for blood transfusions and provide better outcomes after surgery. Therefore, controlling anemia before surgery is extremely important, and could be a lifesaving measure. This pilot, feasibility study is being done for several reasons. First of all, it will test the the safety and effectiveness of using a short-course of two medications, erythropoietin (EPO) and Feraheme (iron given intravenously [IV]), to increase hemoglobin levels in order to improve preoperative anemia, reduce transfusions and lower postoperative complications in anemic patients undergoing heart surgery. Secondly, findings will be used to design a large randomized controlled trial (RCT). The RCT will establish a protocol to actively manage anemia before surgery, thus reducing transfusions during surgery and improving recovery afterwards. It will also help identify valuable information regarding what needs to be done for timely completion of the planned RCT. EPO is a medication approved by the Food and Drug Administration (FDA) used to treat anemia in patients with certain conditions in order to reduce blood transfusions. And although approved for use during surgery, it has not been FDA approved for use in cardiac (heart) or vascular (blood vessels, including veins and arteries) surgery. Common side effects include nausea, vomiting, itching, headache, injection site pain, chills, deep vein thrombosis (blood clot), cough, and changes in blood pressure (BP). Feraheme is an iron replacement product approved for the treatment of low iron anemia in adult patients. It may cause serious allergic reactions, including anaphylaxis (severe, whole body allergic reaction), as well as low BP and excessive iron storage. Patients meeting all eligibility requirements that consent to participate will be randomized into the study. Randomization is being placed by chance (like a flip of a coin) into one of two study groups, the treatment group or the control group. There is an equal chance of being placed into either group, which will be done by a computer. 1. The Treatment Group will receive a 300 unit (U) per kilogram (kg) injection of EPO and a 510 milligram (mg) IV infusion of Feraheme 7-28 days before the day of surgery. And again 1-7 days before the day of surgery, a second dose of both of these medications will be given. The third dose, of EPO only, will be administered 2 days after surgery. Before initiating a dose or giving a subsequent dose, laboratory parameters will be measured to assess the hemoglobin level and response to the medication. If blood values increase too rapidly or are too high, the meds will not be started or, if already dosed, they will not be given again. 2. The Control Group will receive no preoperative intervention for anemia unless lab results show iro
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Philip Greilich
12788
All
18 Years to 80 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT02189889
STU 092012-045
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Inclusion Criteria:

• between the age of 18 and 80 years old
• diagnosed with preoperative anemia, defined as hemoglobin <13.0 grams per deciliter (g/dL)
• scheduled for elective cardiac surgery (CABG, valve, or CABG/valve), including both first time and repeat procedures
• documented negative pregnancy test within 7 days prior to the procedure for females of child-bearing potential
• a written informed consent prior to any procedure, using a form that is approved by the UT Southwestern Institutional Review Board
• agreement to be compliant
Exclusion Criteria:

• uncontrolled hypertension (defined as systolic pressure greater than 180 millimeters of mercury (mmHg), diastolic pressure greater than 100mmHg, not adequately controlled by anti-hypertensive therapy at the time of procedure)
• current renal failure on dialysis or serum creatinine >3.0 milligrams per deciliter (mg/dL)
• unstable angina (defined by chest pain and EKG changes indicating ischemia at rest)
• thromboembolism within the past year
• current active primary or metastatic malignancy or history of myeloid malignancy
• seizures within the past year
• history of stroke within the last 6 months
• patients who have platelet count lower than 50,000 per cubic millimeter (mm3) or coagulation abnormality
• sepsis or bacteremia defined by positive blood culture
• patients who have known hypersensitivity to EPO or any of its components
• patients who have known hypersensitivity to Feraheme or any of its components
• patients who refuse blood transfusion, (i.e. Jehovah's Witnesses)
• pregnant or breast feeding
• patients who are unable to provide informed consent or who has inability to understand or corporate with study procedure
Drug: EPO, Drug: Feraheme
Anemia, Cardiovascular Disease
Active preoperative anemia management, Erythrocyte transfusion, RBC transfusion, Red cell transfusion, Transfusion in cardiac surgery, Anemia treatment with erythropoietin, Anemic cardiac surgery patients, Erythrocyte stimulating agent (ESA), Iron deficiency anemia, EPO, Feraheme
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Evaluation of the Duration of Therapy for Thrombosis in Children (Kids-DOTT)

The Kids-DOTT trial is a randomized controlled clinical trial whose primary objective is to evaluate non-inferiority of shortened-duration (6 weeks) versus conventional-duration (3 months) anticoagulation in children with first-episode acute venous thrombosis. The first stage of the trial has consisted of a pilot/feasibility component, which then continues as the definitively-powered trial.
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Ayesha Zia
149180
All
up to 20 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT00687882
STU 052011-085
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Inclusion Criteria:
1. Children (birth to <21 years of age) with radiologically-confirmed acute venous thrombosis in the past 30 days 2. In the opinion of the investigator, the venous thrombosis was a provoked (i.e., non-spontaneous) event (e.g.: hospitalization; Central venous catheterization; infection; dehydration; surgery; trauma; immobility; use of estrogen-containing oral contraceptive pills; flare of autoimmune/rheumatologic condition).
Exclusion Criteria:
1. prior episode of VTE; 2. presence or history of cancer; 3. systemic lupus erythematosus 4. known pulmonary embolism (PE), except when limited to peripheral cavitary lesions representing septic emboli; (N.B. imaging for PE should only have been based upon clinical signs/symptoms, and is not a study procedure or requirement) 5. Use of, or intent to use, thrombolytic therapy 6. Patients with congenital cardiac disease involving a single or hypoplastic ventricle or otherwise requiring an intracardiac shunt 7. Moderate/severe anticoagulant deficiency as defined by any one of the following: 1. protein C <20 IU/dL if patient is ≥3 months of age, or protein C below lower limit of detection if patient is <3 months of age; 2. antithrombin <30 IU/dL if patient is ≥3 months of age, or antithrombin below lower limit of detection if patient is <3 months of age; 3. protein S (free antigen or activity) <20 IU/dL.
Other: Shortened duration (6 weeks) of anticoagulant therapy, Other: Conventional duration (3 months) of anticoagulant therapy, Other: No Intervention, Other: No Intervention
Venous Thrombosis
Venous Thromboembolism, Postthrombotic Syndrome, Antithrombotic Therapy, Duration of Therapy, Children
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The BROADEN Study: A Study of Volanesorsen (Formerly ISIS-APOCIIIRx) in Patients With Familial Partial Lipodystrophy

The purpose of this study is to evaluate the efficacy and safety of volanesorsen (IONIS-APOCIIIRx) given for 52 weeks in patients with Familial Partial Lipodystrophy. Patients will then be allowed to continue in a 2 year Open Label Extension of the study.
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Abhimanyu Garg
12461
All
18 Years to 65 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT02527343
STU 082015-082
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Inclusion Criteria:

• Clinical diagnosis of FPL plus diagnosis of type 2 diabetes mellitus and hypertriglyceridemia.
• Diagnosis of FLP is based on deficiency of subcutaneous body fat in a partial fashion assessed by physical examination and low skinfold thickness in anterior thigh by caliper measurement: men (≤ 10 mm) and women (≤ 22 mm), and at least 1 of the following:
• Genetic diagnosis of familial PL (e.g., mutations in LMNA, PPAR-γ, AKT2, CIDEC, PLIN1 genes) OR -Family history of FPL or family history of abnormal and similar fat distribution plus 1 Minor Criteria OR -2 Minor Criteria (In the absence of FPL-associated genetic variant or family history) and BMI< 35 kg/m2 Minor Criteria 1. Requirement for high doses of insulin, e.g., requiring ≥ 200 U/day, ≥ 2 U/kg/day, or currently taking U-500 insulin 2. Presence of acanthosis nigricans on physical examination 3. Evidence/history of polycystic ovary syndrome (PCOS) or PCOS-like symptoms (hirsutism, oligomenorrhea, and/or polycystic ovaries) 4. History of pancreatitis associated with hypertriglyceridemia 5. Evidence of non-alcoholic fatty liver disease
• Hepatomegaly and/or elevated transaminases in the absence of a known cause of liver disease or radiographic evidence of hepatic steatosis (e.g., on ultrasound or CT)
• Diagnosis of Type 2 diabetes mellitus as defined by the American Diabetes Association Standards of Medical Care in Diabetes 2015) made at least 12 weeks prior to the Screening visit, and 2 of the following:
• on standard-of-care anti-diabetic therapy, and
• HbA1c ≥ 7% to ≤ 10% at Screening.
• Hypertriglyceridemia is defined as Fasting TG levels ≥ 500 mg/dL (≥ 5.7 mmol/L) at Screening and Qualification visit.
• If the fasting TG value at Screening and/or Qualification visit is < 500 mg/dL (< 5.7 mmol/L) but ≥ 350 mg/dL (≥ 4.0 mmol/L) up to 2 additional tests may be performed in order to qualify
Exclusion Criteria:

• A diagnosis of generalized lipodystrophy
• A diagnosis of acquired partial lipodystrophy
• Acute pancreatitis within 4 weeks of Screening
• History within 6 months of Screening of acute or unstable cardiac ischemia (myocardial infarction, acute coronary syndrome, new onset angina), stroke, transient ischemic attack, or unstable congestive heart failure requiring a change in medication
• Major surgery within 3 months of Screening
• Treatment with Metreleptin within the last 3 months prior to Screening
• Previous treatment with ISIS-APOCIIIRx
Drug: volanesorsen, Drug: Placebo
Familial Partial Lipodystrophy
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Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration (IBPS)

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

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

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

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Ty Shang
137563
All
45 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03192215
STU 112017-065
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Inclusion Criteria:

• Age ≥ 45 years.
• Clinical diagnosis of ischemic stroke + brain imaging to rule out hemorrhagic stroke.
• Modified Rankin Scale (MRS) score ≤ 4.
• Ability to be randomized within 3 to 120 days after stroke onset.
• ESUS, defined as all of the following:
• Stroke detected by CT or MRI that is not lacunar. Lacunar is defined as a subcortical (this includes pons and midbrain) infarct in the distribution of the small, penetrating cerebral arteries whose largest dimension is ≤1.5 cm on CT or ≤2.0 cm on MRI diffusion images/<1.5 cm on T2 weighted MR images. The following are not considered lacunes: multiple simultaneous small deep infarcts, lateral medullary infarcts, and cerebellar infarcts. Patients with a clinical lacunar stroke syndrome and no infarct on imaging are excluded.
• Absence of extracranial or intracranial atherosclerosis causing ≥50 percent luminal stenosis of the artery supplying the area of ischemia. Patients must undergo vascular imaging of the extracranial and intracranial vessels using either catheter angiography, CT angiogram (CTA), MR angiogram (MRA), or ultrasound, as considered appropriate by the treating physician and local principal investigator.
• No major-risk cardioembolic source of embolism, including intracardiac thrombus, mechanical prosthetic cardiac valve, atrial myxoma or other cardiac tumors, mitral stenosis, myocardial infarction within the last 4 weeks, left ventricular ejection fraction <30 percent, valvular vegetations, or infective endocarditis). Patent foramen ovale is not an exclusion. All patients must undergo electrocardiogram, transthoracic or transesophageal echocardiography (TTE or TEE) and at least 24 hours of cardiac rhythm monitoring (Holter monitor or telemetry or equivalent). Additional cardiac imaging, such as cardiac MRI, or cardiac CT will be performed at the discretion of the local treating physician and principal investigator. Additional cardiac rhythm monitoring, such as monitored cardiac outpatient telemetry (MCOT) or an implanted cardiac monitor, will be at the discretion of the treating physician and local principal investigator.
• No other specific cause of stroke identified, such as arteritis, dissection, migraine, vasospasm, drug abuse, or hypercoagulability. Special testing, such as toxicological screens, serological testing for syphilis, and tests for hypercoagulability, will be performed at the discretion of the treating physician and local principal investigator.
Exclusion Criteria:

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

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