Clinical trials: Single-ventricle Fontan
Single Ventricle
Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients
This pilot study is aimed at assessing the short-term effects of Tadalafil on the hemodynamic response to exercise and exercise capacity in patients with Fontan circulation.
- Trial name
- NCT01291069
- Testing
- Tadalafil Citrate, Sugar pill
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Utah
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 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
Lymphatic Abnormalities, Lymphatic Edema
Lymphatic Function in Patients With a Fontan-Kreutzer Circulation
The lymphatics regulate the interstitial fluid by removing excessive fluid. It represents an extremely important step in the prevention of edema.
- Conditions
- Lymphatic Abnormalities, Lymphatic Edema, Univentricular Heart
- Trial name
- NCT03379805
- Testing
- Near Infrared Fluorescence Imaging, Non-contrast MRI, Strain Gauge Plethysmography
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Fontan Procedure, Hypoplastic Left Heart Syndrome
Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients
In this study, investigators will evaluate the effect of vitamin C on endothelial function, exercise tolerance and quality of life in patients with a single ventricle who have been palliated to Fontan physiology.
- Conditions
- Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia
- Trial name
- NCT00974025
- Testing
- Vitamin C
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Congenital Heart Disease, Single Ventricle
Diffuse Myocardial Fibrosis in Fontan Patients
The purpose of this protocol is to measure the relaxation of the heart in subjects with single ventricles who have undergone the surgical Fontan procedure.
- Conditions
- Congenital Heart Disease, Single Ventricle, Myocardial Fibrosis
- Trial name
- NCT01929174
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Oregon Health and Science University
Single Ventricle Fontan Palliation
The Effects of Ambrisentan on Exercise Capacity in Fontan Patients
Hypothesis: Patients with a Fontan type palliation are limited by preload, or the rate at which blood returns to the heart after passively traversing the pulmonary capillary bed.
- Trial name
- NCT01971580
- Testing
- Ambrisentan
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Washington University School of Medicine
Fontan Circulation, Single Ventricle Heart Disease
CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation
The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 3 months affects peripheral venous pressure at rest and during exercise in adults with failing Fontan circulation.
- Conditions
- Fontan Circulation, Single Ventricle Heart Disease, HFpEF - Heart Failure With Preserved Ejection Fraction
- Trial name
- NCT06762964
- Testing
- Dapagliflozin tablet
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Mayo Clinic
Congenital Heart Disease, Univentricular Heart
Effect of Muscle Strengthening Training in Adults with Fontan Circulation
Aim: to evaluate the effect of muscle strengthening exercise training in adults with Fontan circulation compared to healthy controls.
- Trial name
- NCT05454254
- Testing
- Individualised muscle strengthening exercise training protocol.
- Where
- Sweden
- Volunteers
- 20 people
- Sponsor
- Umeå University
Congenital Heart Disease (CHD), Univentricular Heart
Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD
This prospective cohort study evaluates differences in clinical outcomes between pulmonary oligemia and pulmonary plethora in patients with cyanotic congenital heart disease and univentricular heart physiology undergoing staged…
- Trial name
- NCT07535203
- Testing
- Fontan Procedure
- Where
- Indonesia
- Volunteers
- 52 people
- Sponsor
- Sisca Natalia Siagian
Hypoplastic Left Heart Syndrome, Tricuspid Atresia
Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.
The purpose of this study is to determine whether Bosentan is an effective and safe treatment to adolescent and adult (15 years and older) patients, born with one ventricle of the heart instead of two (single ventricle…
- Conditions
- Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Other Specified Congenital Anomalies of Heart
- Trial name
- TEMPO (NCT01292551)
- Testing
- Bosentan
- Where
- 4 sites in Denmark, Sweden
- Volunteers
- 75 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Tetralogy of Fallot, Transposition of the Great Vessels With an Arterial Switch
The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
Hypothesis: By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the great vessels with a prior atrial switch, and single ventricle "Fontan" patients, incident heart failure will be delayed…
- Conditions
- Tetralogy of Fallot, Transposition of the Great Vessels With an Arterial Switch, Single Ventricle With a Fontan Palliation
- Trial name
- NCT01971593
- Testing
- Eplerenone
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Washington University School of Medicine
Single-ventricle, Fontan Circulation
Venous Compression in Fontan
The aim of this study is to investigate whether venous compression garments increase exercise stroke volume in patients with Fontan circulation. To address this aim, we will test the following hypotheses: 1.
- Trial name
- NCT07220226
- Testing
- Lower extremity compression garments, Without compression garments
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Univentricular Heart
Prospective Evaluation of Univentricular Hearts
Univentricular heart defects are among the most complex congenital malformations. The treatment of these patients usually includes 3 operations and accompanying diagnostics, some of which are invasive, within the first 3 to 4…
- Trial name
- NCT05620030
- Testing
- Univentricular Heart
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- University of Erlangen-Nürnberg Medical School
Heart Failure Congenital, Single-ventricle
REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life. 1.
- Trial name
- NCT06150950
- Testing
- Cardiac rehabilitation, Usual care
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Stanford University
Fontan Procedure, Hypoplastic Left Heart Syndrome
Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques
The investigators are beginning a clinical research study here at UCSF to learn more about how hearts with single ventricles work.
- Conditions
- Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Double Inlet Left Ventricle
- Trial name
- NCT01107990
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Failure of Fontan Type Circulation, Fenestration
Occlutech AFR Fontan Study
The goal of this observational clinical study look at the safety and effectiveness of the Occlutech Atrial Flow Regulator in the treatment of patients with failing Fontan circulation.
- Conditions
- Failure of Fontan Type Circulation, Fenestration, Univentricular Heart, Congenital Anomaly
- Trial name
- NCT07532369
- Testing
- Occlutech Atrial Flow Regulator Retrospective Data Collection
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- Occlutech International AB
Failing Fontan Physiology, Failing Fontan
The Destination Therapy Evaluation for Failing Fontan Study
Purpose: The purpose of the Destination Therapy Evaluation for Failing Fontan Study (DEFINe Study) is to perform a single center physician-investigator led feasibility study to initiate examination of the safety and efficacy of…
- Conditions
- Failing Fontan Physiology, Failing Fontan, Single-ventricle, Single-ventricle Fontan
- Trial name
- DEFINe (NCT01149603)
- Testing
- HeartMate II Ventricular Assist Device
- Where
- United States
- Sponsor
- Timothy Icenogle, MD
Congenital Heart Disease
Transfusion Strategies in Pediatric Cardiothoracic Surgery
The purpose of this study is to determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects.
- Trial name
- NCT00350220
- Testing
- transfusion strategy, Low Hb transfusion group
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Rochester
Univentricular Heart, Microvascular Dysfunction
Cardiac Magnetic Resonance Stress-perfusion Study in Patinets with Fontan Circulation
Univentricular heart (UVH) is a severe congenital heart disease. Accurate advanced non-invasive diagnostic methods is limited. Cardiovascular magnetic resonance (CMR) imaging has evolved as a particularly useful tool for the…
- Conditions
- Univentricular Heart, Microvascular Dysfunction, Heart Failure, Magnetic Resonance
- Trial name
- CMR_TCPC (NCT06735521)
- Testing
- Cardiac magnetic resonance stress-perfusion
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- Karolinska Institutet