Clinical trials: Single Ventricle
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
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, Left Ventricular Dysfunction
Effects of Viagra on Heart Function in Patients With Heart Failure
Sildenafil (Viagra) is known to reduce pulmonary hypertension. Heart failure patients also have pulmonary hypertension and several recent reports have shown that sildenafil leads to an improvement in their exercise capacity.
- Trial name
- NCT00781508
- Testing
- sildenafil
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- MetroHealth Medical Center
Heart Defects, Congenital, Heart Failure, Congestive
Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network
This study will evaluate the efficacy and safety of administering an angiotensin converting enzyme inhibitor (ACE-I) (enalapril) to infants with a functional single ventricle.
- Trial name
- ISV (NCT00113087)
- Testing
- Enalapril
- Where
- 9 sites in United States, Canada
- Volunteers
- 230 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Heart Defects, Congenital
Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network
This trial will evaluate the efficacy and safety of the modified Blalock-Taussig shunt (MBTS) compared to the right ventricle to pulmonary artery (RV-to-PA) shunt; compare the effect of the MBTS to that of the RV-to-PA shunt on…
- Trial name
- NCT00115934
- Testing
- Blalock-Taussig pulmonary artery shunt, Right ventricular to pulmonary artery shunt
- Where
- 13 sites in United States, Canada
- Volunteers
- 555 people
- Sponsor
- Carelon Research
Pleural Effusion, Single-ventricle
Use of Vasopressin Following the Fontan Operation
The purpose of this pilot study is to prepare for a larger study to determine whether Vasopressin following the Fontan operation will decrease chest tube output and duration.
- Trial name
- NCT02975999
- Testing
- Vasopressin, Normal Saline
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Wake Forest University Health Sciences
Pulmonary Arterial Hypertension
A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging
The purpose of the study is to assess the effects of selexipag on right ventricular (RV) function in participants with Pulmonary arterial hypertension (PAH).
- Trial name
- RESTORE (NCT04435782)
- Testing
- JNJ-67896049
- Where
- 35 sites in United States, Argentina and 13 more
- Volunteers
- 9 people
- Sponsor
- Actelion
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
Congenital Heart Disease
Endothelin Blockade in Patients With Single Ventricle Physiology
Recent studies have shown beneficial effects of sildenafil in patients with single ventricle congenital heart disease. The purpose of this study is to determine whether Bosentan, a drug with similar effects, will have similar…
- Trial name
- NCT00989911
- Testing
- Bosentan
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of California, Los Angeles
Heart Failure, Congestive
Statin Therapy in Heart Failure: Potential Mechanisms of Benefit
The goal of the investigators' study is to further understand the potentially beneficial effects of statin therapy in patients with heart failure.
- Trial name
- NCT00233480
- Testing
- atorvastatin
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- University of California, Los Angeles
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 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 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 Heart Disease After Fontan Surgery
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular…
- Trial name
- NCT02201342
- Testing
- Udenafil
- Where
- 6 sites in United States, Canada
- Volunteers
- 36 people
- Sponsor
- Mezzion Pharma Co. Ltd
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
Heart Failure
Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure.
- Trial name
- GGF2-1101-1 (NCT01258387)
- Testing
- Glial growth factor 2/ Neuregulin 1β3
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Acorda Therapeutics
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