Clinical trials: Fontan Operation
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
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
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
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 (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
Congenital Heart Surgery, Congenital Heart Disease in Children
Blood Based Assessment of sST2, Taken During and After Surgery, for Pediatric Patients With Heart Defects to Predict Heart Failure.
Patients younger than 18 scheduled for congenital heart surgery will be assessed during and post-operatively as well as at the first follow-up after 9-12 month for the novel biomarker sST2.
- Conditions
- Congenital Heart Surgery, Congenital Heart Disease in Children, Fontan Physiology
- Trial name
- NCT07029230
- Where
- Switzerland
- Volunteers
- 225 people
- Sponsor
- Martin Schweiger
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 Defects, Congenital, Hypoplastic Left Heart Syndrome
Fluid Balance in Children Undergoing Fontan Surgery
This project will evaluate fluid balance and edema formation in children with congenital heart disease in need of a surgical procedure, The Fontan procedure.
- Trial name
- NCT02306057
- Testing
- Pre BCPC, Pre TCPC, BCPC surgery
- Where
- Norway
- Volunteers
- 39 people
- Sponsor
- Oslo University Hospital
Congenital Disorders
Pulmonary Resistance in Fontan Who Have Undergone Heart Transplantation
Clinical evidence reveals that some patients who undergo cardiac transplantation exhibit problems with pulmonary vascular resistance as well.
- Trial name
- NCT00268047
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Children's Healthcare of Atlanta
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
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
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
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
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 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