Clinical trials: Fontan Operation
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
Heart Failure, Congenital Heart Disease
Ventricular and Pulmonary Vascular Reserve After the Fontan Operation
Aim #1: Define and determine the prevalence of pulmonary vascular disease and diastolic dysfunction as assessed by the gold standard of invasive hemodynamic cardiopulmonary exercise testing.
- Trial name
- NCT03853837
- Testing
- rest-exercise echocardiography
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Mayo Clinic
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
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
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
Single-ventricle, Fontan Procedure
Exercise Capacity in Patients With Fontan Procedure
In literature, it has been reported that exercise capacity decreases in single-ventricle patients undergoing Fontan Procedure due to various factors related to surgery and underlying cardiac anomaly.
- Trial name
- NCT05063903
- Testing
- Demographic and clinical characteristics, incremental shuttle walk test, six minute walk test, hand grip strength, M. Quadriceps isometric muscle strength, body composition
- Where
- Turkey (Türkiye)
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
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
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
Congenital Heart Defects, Functional Single Ventricle
Bosentan Therapy in Children With Functional Single Ventricle
Bosentan is a kind of dual endothelin receptor antagonist.The purpose of this study is to investigate if Bosentan therapy can modify the outcome of children with functional single ventricle.
- Trial name
- NCT01662037
- Testing
- Bosentan
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Fontan Physiology
Feasibility and Efficacy of Portable Non-invasive Negative Pressure Ventilation in Fontan Patients
The human heart has 4 chambers: 2 collecting chambers (atria) and 2 pumping chambers (ventricles) to allow blood flow within two distinct circuits: "pulmonary" and "systemic".
- Trial name
- FONTAN-CMR (NCT03251742)
- Testing
- Hayek RTX ventilator
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Congenital Heart Disease, Single Ventricle
Cardiovascular, Pulmonary and Skeletal Muscle Evaluation Postoperative in Fontan Patients: Effects of Exercise Training
Introduction: The Fontan operation is the surgical treatment in most patients with either anatomic or functional single ventricles.
- Conditions
- Congenital Heart Disease, Single Ventricle, Univentricular Heart
- Trial name
- NCT02283255
- Testing
- Aerobic Exercise Training, Inspiratory Muscle Training, No Exercise Training
- Where
- Brazil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
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
Cirrhosis, Liver, Gastroesophageal Varices
Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
The goal of this research is to validate novel non-invasive Magnetic resonance imaging (MRI) biomarkers to detect Gastroesophageal varices (GEV) in patients with cirrhosis, including fractional flow change in the portal vein and…
- Conditions
- Cirrhosis, Liver, Gastroesophageal Varices, Fontan Procedure
- Trial name
- NCT04867954
- Testing
- Ensure Plus®, Pre-clinical validation contrast enhanced MRI, Clinical validation MRI
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
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
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
Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation
Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation
Randomisation between postoperative administration of an ACE-inhibitor or not.
- Trial name
- NCT00263406
- Testing
- Administration of an ACE-inhibitor or not
- Where
- Belgium
- Volunteers
- 40 people
- Sponsor
- University Hospital, Ghent
Fontan Operation, Protein-Losing Enteropathy
Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation
This study is phase 2 open-label, single-arm, multi-center clinical trial to evaluate the efficacy and safety of Camostat mesylate in patients with Protein-losing enteropathy after Fontan operation.
- Conditions
- Fontan Operation, Protein-Losing Enteropathy, Camostat Mesylate
- Trial name
- NCT05474664
- Testing
- Camostat mesylate
- Where
- South Korea
- Volunteers
- 19 people
- Sponsor
- Seoul National University Hospital
Congenital Heart Disease
Ocular and Vision Problems in Patients After Fontan Operation
The purposes of this study are to identify indicators of vision problems and ocular abnormalities in patients with a Fontan circulation through a standardized questionnaire and to correlate the intraocular pressure measured with…
- Trial name
- NCT03170778
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Stanford University
Heart Defects, Congenital
Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery
The staged surgical pathway to treat children with single ventricle heart defects culminates with the Fontan operation. In this procedure, systemic venous return is rerouted directly to the pulmonary arteries, which serves to…
- Trial name
- NCT00543309
- Testing
- nesiritide, milrinone
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- John M Costello