Clinical trials: Fontan Procedure
Liver Fibrosis
Sildenafil for Liver Fibrosis in Adolescents and Adults After Fontan Operation
Fontan operation is currently the most common procedure performed in patients with single-ventricle physiology. This surgery allows for passive caval blood flow to the pulmonary arteries in the absence of a subpulmonary pump and…
- Trial name
- NCT04908657
- Testing
- Sildenafil 20 MG
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- National Taiwan University Hospital
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
Re-Energize Fontan
Survival of children with single ventricles ("half a heart") beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high.
- Trial name
- NCT04195451
- Testing
- Live-Video-Supervised Exercise Intervention, Usual Care then Live-Video Supervised Exercise Intervention
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Stanford University
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
Fontan Operation
Pulmonary Functions Test in Patients After Fontan Operation
Developed in the early 1970s, Fontan Operation has provided palliative care for patients with single ventricle physiology. Single ventricle is a rare subclass of the atrioventricular (AV) alignment abnormalities double inlet and…
- Trial name
- NCT01413308
- Volunteers
- 15 people
- Sponsor
- Rambam Health Care Campus
Heart Failure, Mentorship
The iPeer2Peer Mentorship Program for Young Adults With Heart Disease
Young adults with heart failure, including those who have undergone a heart transplant, experience considerable psychosocial stressors associated with living with a chronic illness, including heightened levels of anxiety and…
- Conditions
- Heart Failure, Mentorship, Peer Support, Peer Support and Chronic Disease
- Trial name
- NCT07119216
- Testing
- Peer Mentorship
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- Samantha Anthony
Pulmonary Hypertension
Study of Remodulin® in Pediatric Pulmonary Hypertension With Single Ventricular Physiology After Fontan Surgery
The aim of this study is to determine the safety and efficiency of Remodulin®（Treprostinil Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH) after Fontan operation with univentricular…
- Trial name
- NCT02865733
- Testing
- Remodulin, distilled water
- Volunteers
- 36 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Fontan, Heart Failure
The Effect of Dapagliflozin on Exercise and Cardiac Functional Status of Patients After Fontan Procedure
While the Fontan operation improves survival for patients with a functional single ventricle, complications like heart failure remain prevalent during follow-up, causing frequent hospitalizations and reduced quality of life.
- Conditions
- Fontan, Heart Failure, Dapagliflozin, Cardiovascular Diseases
- Trial name
- NCT07482943
- Testing
- Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy
- Where
- 2 sites in Hong Kong
- Volunteers
- 30 people
- Sponsor
- The University of Hong Kong
Fontan Circulation, Fontan Procedure
Gut, Inflammation and Nutrition in Adult Patients After Fontan Operation
This observational case-control study aims to investigate intestinal barrier dysfunction, systemic inflammation, and nutritional status in adult patients after Fontan operation.
- Trial name
- GIN-Fontan (NCT06731322)
- Where
- Slovenia
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- University Medical Centre Ljubljana
Fontan Procedure
Cholate Clearance in Fontans
HepQuant is an assay to measure liver function in other forms of liver disease such as hepatitis C. It measures the ability of the liver to process an naturally occurring substance called cholate and has been shown to predict…
- Trial name
- NCT03726229
- Testing
- Cholate assay
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Pennsylvania
Congenital Heart Disease
Microcirculation and Vascular Function After Fontan Surgery
Fontan Surgery is done for children with only one working lower chamber of the heart called the 'Single Ventricle'. This surgery involves making connections between the two big veins that drain oxygen deficient blood to the heart…
- Trial name
- MICROFON (NCT05683067)
- Testing
- Hand Held Capillary Microscopy, Mobile 'O' Graph, quality of life using questionnaires
- Where
- United Kingdom
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- University of Leicester
Congenital Heart Defect
The Effects of Inhaled Nitric Oxide After Fontan Operation
Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance.
- Trial name
- NCT00945529
- Testing
- inhaled nitric oxide (iNO)
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Ellen Spurrier
Congenital Heart Disease
Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function
Primary Objective: To determine if impairments in cardiac and musculoskeletal function and metabolism exist in Fontan children. Secondary Objectives: 1. To determine if impairments do exist, are they related to exercise capacity.
- Trial name
- NCT02004756
- Testing
- Exercise Program
- Where
- Canada
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Heart Defects, Congenital
Physical Activity in Fontan Patients
The purpose of this study is to determine which is the most effective intervention for increasing lifestyle physical activity in Fontan patients: an education (stage of change) intervention or a physical activity (mastery…
- Trial name
- NCT00363363
- Testing
- Physical Activity, Education
- Where
- Canada
- Volunteers
- 64 people
- Sponsor
- The Hospital for Sick Children
Fontan Operation
Stage 3 Fontan Operation Liver Ultrasound Study
The purpose of this study is to compare the liver stiffness, which can be caused by congestion and fibrosis in pediatric patients before and after a Fontan heart operation.
- Trial name
- NCT02269709
- Testing
- ARFI Ultrasound
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Michigan
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
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
Single-ventricle, Congenital Heart Disease
Fontan Imaging Biomarkers (FIB) Study
The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of blood and urine biomarkers to imaging parameters of ventricular mechanics.
- Trial name
- FIB (NCT03119090)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Boston Children's Hospital
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