Clinical trials: Fontan Procedure
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
Fontan Palliation
Upright Versus Supine Exercise Testing in Fontan-palliated Patients
Fontan-palliated patients comprise an interesting group of single-ventricle patients who are dependent upon passive return of blood from the body to the lungs.
- Trial name
- NCT00633815
- Testing
- Supine positioning, Upright positioning
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Michigan
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
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
Tricuspid Atresia, Heart Defects, Congenital
Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
OBJECTIVES: I. Determine the pharmacokinetics of exogenous liothyronine administered in children undergoing the modified Fontan procedure. II.
- Trial name
- NCT00004828
- Testing
- liothyronine I 131
- Volunteers
- 28 people
- Sponsor
- FDA Office of Orphan Products Development
Prevention of Venous Thromboembolism, Congenital Heart Disease
An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure
This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their doctors after a heart surgery…
- Conditions
- Prevention of Venous Thromboembolism, Congenital Heart Disease, Fontan Procedure, Children
- Trial name
- NCT06193863
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Japan
- Volunteers
- 61 people
- Sponsor
- Bayer
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
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
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
Fontan Palliation, Congenital Heart Disease
Cardio Pulmonary Exercise Testing in Patients Post the Fontan Palliation in Comparison With Patients With Repaired Congenital Heart Disease and Healthy Volunteers.
prospective cardio respiratory evaluation for patients post the Fontan palliation for single ventricle, compared to subjects post successful cardiac repaired surgery compared to healthy volunteers in order to evaluate the…
- Trial name
- NCT02659462
- Testing
- Cardio Pulmonary Exercise Testing
- Where
- Israel
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Rambam Health Care Campus
Circulatory Perfusion Disorder, Congenital Heart Disease
Early Use of Vasopressin in Post-Fontan Management
This is an investigator initiated, prospective, single-center, double-blinded, randomized, placebo-controlled trial of post-operative low dose vasopressin infusions as an early treatment of low systemic perfusion in pediatric…
- Conditions
- Circulatory Perfusion Disorder, Congenital Heart Disease, Single-ventricle
- Trial name
- VAMP (NCT03088345)
- Testing
- Vasopressin, Arginine
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical College of Wisconsin
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
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 Procedure
Clinical Outcomes in Fenestrated Extra-Cardiac Fontan in Low Preoperative Risk Profiles
Evaluation of fenestration benefit in Extra-cardiac total cavo-pulmonary connection (Fontan procedure) in single ventricle anomaly, comparing clinical outcomes of patients with low preoperative risk profiles in prospective study
- Trial name
- NCT03503032
- Testing
- Extracardiac Fontan, Fontan fenestration
- Where
- Saudi Arabia
- Volunteers
- 62 people
- Sponsor
- King Faisal Specialist Hospital & Research Center
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
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
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
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
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
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