Clinical trials: Fontan
Heart Defect, Triscupid Atresia
International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.
- Trial name
- NCT00182104
- Testing
- Warfarin vs ASA
- Where
- 7 sites in Australia, Canada
- Volunteers
- 111 people
- Sponsor
- Hamilton Health Sciences Corporation
Single Ventricle
Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation
The purpose of this study is to test the efficacy of treprostinil (TRE) in the perioperative non-fenestrated, extracardiac Fontan patients in order to reduce duration of chest tube drainage (in days).
- Trial name
- NCT02498444
- Testing
- Treprostinil
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Stanford University
Fontan Palliation
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
The purpose of this study is to find out more about the effectiveness of Tadalafil in improving hemodynamic capabilities, endothelial function, and end-organ function in patients who have previously undergone a Fontan Palliation.
- Trial name
- NCT05206955
- Testing
- Tadalafil
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Mayo Clinic
Univentricular Heart
Fontan-Sprechstunde
After successful Fontan surgery, the risk of mortality in childhood is only low. Unfortunately, some of the patients suffer from Fontan-typical long-term complications in the long-term course, whereby protein loss neuropathy must…
- Trial name
- NCT05563376
- Testing
- Univentricular Hearts
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- University of Erlangen-Nürnberg Medical School
Pulmonary Hypertension, Right Ventricular Outflow Tract Dysfunction
Feasibility of Non-invasive Hemodynamic Assessment by 5D Flow in Congenital Heart Disease
This study evaluates whether new flow parameters of the cardiac magnetic resonance imaging (MRI) allow evaluation of parameters for which usually invasive rigth-left heart catheterization are necessary.
- Conditions
- Pulmonary Hypertension, Right Ventricular Outflow Tract Dysfunction, Fontan Circulation
- Trial name
- NCT07742046
- Testing
- Right-left heart catheterization in magnetic resonance imaging (MRI)
- Where
- Switzerland
- Volunteers
- 130 people
- Sponsor
- Tobias Rutz
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 With Fontan Circulation
An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.
The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study…
- Trial name
- RUBATO OL (NCT03775421)
- Testing
- macitentan 10 mg
- Where
- 19 sites in United States, Australia and 9 more
- Volunteers
- 112 people
- Sponsor
- Actelion
Tricuspid Atresia, Hypoplastic Left Heart Syndrome
Biomarker Study for Heart Failure in Children With Single Ventricle Physiology
The purpose of this study is to determine if children with heart disease where there is only one pumping chamber("ventricle") have proteins (biomarkers") in the blood that can be used to monitor the function of their heart.
- Conditions
- Tricuspid Atresia, Hypoplastic Left Heart Syndrome, Unbalanced AV Canal
- Trial name
- BHFSVP (NCT00571233)
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- University of California, San Francisco
Dopamine, Protein-Losing Enteropathies
Characterizing the Effect of Dopamine on Markers of Lymph Re-circulation in Fontan-associated Protein-losing Enteropathy
Patients that have undergone a Fontan procedure (surgical correction for single ventricle congenital heart disease) may develop a complication known as protein-losing enteropathy (PLE).
- Conditions
- Dopamine, Protein-Losing Enteropathies, Lymphatic System, Lymph
- Trial name
- NCT03322345
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Michigan
Single-ventricle
Fibrosis and the Fontan
The purpose of this study is to non-invasively characterize the fibrotic consequences of single ventricle physiology, its possible solution and effect on lymphatics.
- Trial name
- NCT04901975
- Testing
- Spironolactone
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- Children's Hospital of Philadelphia
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
Failing Fontan Physiology, Pediatric Congenital Heart Disease
Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology
The purpose of this study is to assess for acute hemodynamic changes after implementation of noninvasive negative pressure ventilation (as compared with spontaneous respiration) in pediatric patients with Fontan failure using…
- Trial name
- NCT03223168
- Testing
- Hayek RTX ventilator
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Michigan
Univentricular Heart
Aesculus Hippocastanum L. on Fontan Circulation
Patients after the Fontan operation at a single institution will be randomized to receive a standardized extract of Aesculus hippocastanum L. (horse chestnut) or placebo for 4 months in a crossover clinical trial.
- Trial name
- NCT04035317
- Testing
- Aesculus Hippocastanum / Horse Chestnut
- Where
- Brazil
- Sponsor
- Casa Espirita Terra de Ismael
Respiratory Muscle Weakness
Inspiratory Training in Children After Fontan
This study will assess physical and respiratory capacity, diaphragmatic mobility and quality of life. Healthy children and children who have undergone Fontan surgery will participate.
- Trial name
- NCT06580808
- Testing
- Fontan Training Group
- Where
- Brazil
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Fontan Circulation
Fontan Circulation and Reproductive Health in a National Swedish Cohort
In the Swedish registry for congenital heart defects, SWEDCON, over 230 patients with single-ventricle circulation are registered in the adult section.
- Trial name
- NCT06258382
- Testing
- Questionnaires and functional test
- Where
- 15 sites in Sweden
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Caroline Lilliecreutz
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
Heart Defects, Congenital
Colloid Osmotic Pressure in Patients With Fontan Circulation
Children born with univentricular heart will go through step surgery and end up with a Fontan circulation. A circulation with cause problems with body fluid balance.This project will evaluate changes in interstitial colloid…
- Trial name
- NCT02443662
- Testing
- Catheterization
- Where
- Norway
- Volunteers
- 12 people
- Sponsor
- Oslo University Hospital
Fontan
TRPV2 Agonists in the Fontan Circulation
There are currently very few proven pharmacologic options available for these patients. The recent discovery of transient receptor potential vanilloid (TRPV) channels, particularly TRPV2 channels, in the cardiovascular system is…
- Trial name
- NCT03965351
- Testing
- Probenecid
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Fontan Circulation
Muscle Function in Patients With Single-chamber Heart
Groundbreaking cardiac surgery has significantly improved survival rates for patients with single-chamber hearts. However, despite these life-saving interventions, the long-term prognosis remains concerning, with an increased…
- Trial name
- Muscle in TCPC (NCT07420660)
- Where
- Sweden
- Volunteers
- 34 people
- Sponsor
- Karolinska Institutet
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