Clinical trials: Single Ventricle Cardiac Anomaly
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)
Congenital Heart Disease, Single-ventricle
Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
Newborns with congenital heart disease (CHD) are at increased risk of developing postpartum and postoperative blood clots after cardiac surgery.
- Conditions
- Congenital Heart Disease, Single-ventricle, Thrombosis
- Trial name
- EVmiRNA (NCT06434207)
- Testing
- Collecting discarded blood samples
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Boston Children's Hospital
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
Single-ventricle
Inspiratory Muscle Therapy in Subjects With Fontan Circulations
Individuals who have undergone the Fontan procedure are uniquely dependent upon respiratory mechanics to support pulmonary blood flow (PBF).
- Trial name
- NCT03339466
- Testing
- Inspiratory muscle therapy
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Heart Failure, Cardiomyopathy, Dilated
Role of Left Ventricular Pacing Site
Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site.
- Conditions
- Heart Failure, Cardiomyopathy, Dilated, Coronary Disease
- Trial name
- NCT00221780
- Testing
- left ventricular pacing
- Where
- France
- Volunteers
- 33 people
- Sponsor
- University Hospital, Bordeaux
Hypoplastic Left Heart Syndrome
Positive Pressure Ventilation and Sternal Closure in HLHS
This study will examine the cardiopulmonary interactions that occur with increasing ventilator settings (PEEP and PIP) in neonates after stage I palliation for hypoplastic left heart syndrome before and after sternal closure.
- Trial name
- NCT02455713
- Testing
- PEEP and PIP
- Where
- Canada
- Sponsor
- The Hospital for Sick Children
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
Congenital Disorders
Outcomes of Children With Congenital Single Ventricle Heart
Congenital heart disease affects 1 in 100 newborn babies each year and more than 2,000,000 Americans have a congenital heart defect.
- Trial name
- NCT00266968
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Children's Healthcare of Atlanta
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
Single Ventricle Cardiac Anomaly
A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery
An initial feasibility and safety study evaluating the use of autologous tissue engineered vascular grafts as extra cardiac total cavopulmonary connection (EC TCPC) conduits in children with single ventricle anomalies.
- Trial name
- NCT01034007
- Testing
- Tissue Engineered Vascular Grafts
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Christopher Breuer
Single-ventricle
Association of Near Infrared Spectroscopy With Interstage Outcomes
The purpose of this study is to assess the utility of renal near infrared spectroscopy in the outpatient setting during the interstage period.
- Trial name
- NCT06538571
- Testing
- Near infrared spectroscopy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Advocate Hospital System
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, Myocardial Fibrosis
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.
- Trial name
- NCT03263312
- Testing
- Exercise
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Maria Bano
Hypoplastic Left Heart Syndrome, Single Ventricle
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Trial name
- APOLLON (NCT02781922)
- Testing
- Autologous cardiac stem cells (JRM-001)
- Where
- 4 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
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
Single-ventricle, Fontan Procedure
Hemodynamic, Vascular and Muscular Parameters of Exercise Capacity in Single-Ventricle Patients With Fontan Procedure
After the Fontan procedure applied in patients with a functional or anatomical single ventricle, patients are faced with significant morbidity and mortality risk.
- Conditions
- Single-ventricle, Fontan Procedure, Hemodynamic Instability, Arterial Stiffness
- Trial name
- NCT05011565
- Testing
- Demographic and Clinical Characteristics, Maximal Exercise Capacity, Submaximal Exercise Capacity, Hemodynamic Parameters, Muscle Strength, Muscle Oxygenation, Vascular Function
- Where
- Turkey (Türkiye)
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
Congenital Heart Disease, Nutritional Failure
Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease
The purpose of this study is to understand the causes of growth failure and to define biochemical markers of nutritional failure in patients with single ventricle Congenital Heart Disease (CHD).
- Trial name
- NCT01821287
- Testing
- CHD
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Congenital Heart Disease
Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome
There have been many improvements in the care of children with hypoplastic left heart syndrome (HLHS). This has helped these children survive longer.
- Trial name
- NCT00399555
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Emory University
Congenital Heart Disease, SRV Dependent
Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD
Researchers want to better understand what happens to the heart when the autologous (from one's own body) stem cells are injected directly into muscle of the right side of the heart during the Fontan (Stage III) surgery.
- Trial name
- NCT04907526
- Testing
- Autologous mononuclear cells
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Timothy J Nelson, MD, PhD