Clinical trials: Single Ventricle Heart Disease
Hypoplastic Left Heart Syndrome, Single Ventricle
Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology
Hypoplastic left heart syndrome (HLHS) and related anomalies involved a single ventricle are characterized by hypoplasia of the left heart and the aorta with compromised systemic cardiac output.
- Conditions
- Hypoplastic Left Heart Syndrome, Single Ventricle, Heart Failure
- Trial name
- TICAP (NCT01273857)
- Testing
- Autologous cardiac progenitor cell transplantation, staged shunt procedure
- Where
- Japan
- Volunteers
- 14 people
- Sponsor
- Okayama University
Ventricular Tachycardia, Arrhythmia
Imaging With a Radio Tracer to Guide VT Ablations
Some patients are at risk for life-threatening fast heart rates. These can frequently be treated by using a catheter inside the heart to burn away the cells that create the fast heart rates.
- Trial name
- NCT01250912
- Testing
- 123I-metaiodobenzylguanidine
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Maryland, Baltimore
Heart Disease
Sildenafil in Single Ventricle Patients
Patients with single ventricle anatomy undergo staged surgical palliation. The result is an "in series" circulation with pulmonary blood flow and cardiac output directly related to pulmonary vascular resistance.
- Trial name
- NCT01169519
- Testing
- Sildenafil by injection
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Duke University
Ischemic Cardiomyopathy
Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure
This is a phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cells both alone and in combination…
- Trial name
- CONCERT-HF (NCT02501811)
- Testing
- Mesenchymal Stem Cells (MSC), c-kit+ cells
- Where
- 7 sites in United States
- Volunteers
- 125 people
- Sponsor
- The University of Texas Health Science Center, Houston
Single Ventricle Heart Disease After Fontan Surgery
Study of Effects of Sildenafil on Patients With Fontan Heart Circulation
The study will investigate the cardiovascular effects of sildenafil on patients with Fontan circulation. Recent studies suggest that sildenafil may improve exercise in patients with Fontan circulation.
- Trial name
- NCT01815502
- Testing
- Cardiac catheterization
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical University of South Carolina
Single Ventricle Physiology
Training in Exercise Activities and Motion for Growth
To determine if an exercise program of passive range of motion (ROM) is safe and feasible in infants with single ventricle (SV) physiology after their Norwood procedure.
- Trial name
- T4G (NCT01917084)
- Testing
- Passive range of motion (ROM) exercise
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Carelon Research
Hypoplastic Left Heart Syndrome
Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome
Researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with…
- Trial name
- NCT03779711
- Testing
- Autologous (self) mononuclear cells derived from umbilical cord blood, Stage II Surgical repair
- Where
- 8 sites in United States
- Volunteers
- 95 people
- Sponsor
- Timothy J Nelson, MD, PhD
Aortic Valve Stenosis
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for…
- Trial name
- NCT03517436
- Testing
- TAVR with CENTERA THV
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Edwards Lifesciences
Single-ventricle, Heart Diseases
Colchicine in Postoperative Fontan Patients
The investigators found that there is inflammation in the chest drainage in patients after the Fontan operation. The investigators want to test the theory that Colchicine, an anti- inflammatory medication, can decrease the…
- Trial name
- CPFP (NCT03575572)
- Testing
- Colchicine
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Michigan
Heart Failure
Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone
To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic…
- Trial name
- ARTS-HF (NCT01807221)
- Testing
- Finerenone (BAY94-8862), Inspra (eplerenone)
- Where
- 172 sites in United States, Australia and 23 more
- Volunteers
- 1,066 people
- Sponsor
- Bayer
Heart Failure, LVAD
The Left Ventricular Assist Device (LVAD) Off or On Pump Implantation Study
The purpose of this study is to compare adverse events after off-pump LVAD surgery or on-pump LVAD surgery.
- Trial name
- LVAD-ON-OFF (NCT04219618)
- Testing
- Off-Pump, On-Pump
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- The University of Texas Health Science Center, Houston
Hypoplastic Left Heart Syndrome, Tricuspid Atresia
Sildenafil After the Fontan Operation
In this study, the investigators will evaluate the effect of sildenafil on exercise tolerance in patients with a single cardiac ventricle who have undergone the Fontan operation.
- Trial name
- SAFO (NCT00507819)
- Testing
- Sildenafil
- Volunteers
- 28 people
- Sponsor
- Children's Hospital of Philadelphia
Aortic Stenosis
DEFLECT I: Keystone Heart Embolic Deflection Trial
This is a research study using the Keystone Heart Embolic Deflection Device and involving patients with aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT01448421
- Testing
- Keystone Heart Embolic Deflection Device
- Volunteers
- 37 people
- Sponsor
- Keystone Heart
Circulatory Perfusion Disorder, Congenital Heart Disease
Early Use of Vasopressin in Post-Fontan Management
This is an investigator initiated, prospective, single-center, double-blinded, randomized, placebo-controlled trial of post-operative low dose vasopressin infusions as an early treatment of low systemic perfusion in pediatric…
- Conditions
- Circulatory Perfusion Disorder, Congenital Heart Disease, Single-ventricle
- Trial name
- VAMP (NCT03088345)
- Testing
- Vasopressin, Arginine
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical College of Wisconsin
Heart Failure, Ventricular Dysfunction, Left
Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone
The purpose is to study if HF treatment guided by NTproBNP in addition to clinical symptoms and signs is more effective than treatment guided by clinical symptoms and signs alone in patients with HF and left ventricular systolic…
- Trial name
- NCT00391846
- Testing
- Captopril, Enalapril, Lisinopril
- Where
- 39 sites in Sweden
- Volunteers
- 252 people
- Sponsor
- AstraZeneca
Hypoplastic Left Heart Syndrome, Hypoplastic Right-sided Heart Complex
Ambrisentan in Single Ventricle
Purpose: To evaluate the pharmacokinetics, bioavailability and hemodynamic efficacy of ambrisentan after Fontan surgical palliation of single ventricle heart defects.
- Trial name
- NCT02080637
- Testing
- Ambrisentan
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Kevin Hill
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics
The aim of this study is to assess whether oral Riociguat affects the left ventricular contractility and relaxation in patients with pulmonary hypertension associated with left ventricular systolic dysfunction
- Trial name
- HEARTWORK (NCT01065051)
- Testing
- Riociguat (Adempas, BAY63-2521)
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Bayer
Single Ventricle, Fontan
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.
- Trial name
- NCT02946892
- Testing
- Carvedilol
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Texas Southwestern Medical Center
Single Ventricle Heart Disease
Fontan Udenafil Exercise Longitudinal Assessment Trial
This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent subjects who have undergone the Fontan…
- Trial name
- FUEL (NCT02741115)
- Testing
- Udenafil
- Where
- 30 sites in United States, Canada and 1 more
- Volunteers
- 400 people
- Sponsor
- Mezzion Pharma Co. Ltd
Single Ventricle Heart Disease
Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness
A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.
- Trial name
- FALD (NCT03430583)
- Testing
- Udenafil
- Where
- 17 sites in United States, Canada
- Volunteers
- 88 people
- Sponsor
- Mezzion Pharma Co. Ltd