Clinical trials: Fontan Procedure
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
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
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 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
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 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
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
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 Disorders
Spironolactone in Patients With Single Ventricle Heart
Ultrasound is a technique that can provide images of the blood vessels such as arteries. The size of the arteries, such as the main blood vessel in the arm, can change under different conditions.
- Trial name
- NCT00211081
- Testing
- Spironolactone (drug)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Emory University
Fontan Procedure, Altitude
Cardiopulmonary Adaptation of Short Term Exposure to High Altitude in Fontan Patients: Swiss Fontan & ALtitude COllaboratioN (FALCON) Study
Important advances in cardiac surgery, intensive care, and diagnostic modalities over the last decades have led to a steady growth in the number of adults with congenital heart defects.
- Trial name
- FALCON (NCT02237274)
- Testing
- High altitude exposition
- Where
- Switzerland
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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
Fontan Procedure, Fontan Circulation
A Simple Method for Monitoring the End-organ Function in Patients With Fontan Circulation.
This is a multicenter, observational, cross-sectional study designed to investigate whether a parsimonious set of low-cost, accessible functional, anthropometric, and physiological measurements can help identify multisystem…
- Trial name
- NCT07874165
- Volunteers
- 150 people
- Sponsor
- Universidad de Murcia
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
Congenital Disorders
Intra-Atrial vs. Extra-Cardiac Technique During Fontan Operation
Our aim is a retrospective chart review seeking to determine any differences in the main clinical and outcome variables as well as general outcome data such as functional recovery, readmission rates, somatic growth and mortality.
- Trial name
- NCT00266942
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Children's Healthcare of Atlanta
Single Ventricle Fontan Palliation
The Effects of Ambrisentan on Exercise Capacity in Fontan Patients
Hypothesis: Patients with a Fontan type palliation are limited by preload, or the rate at which blood returns to the heart after passively traversing the pulmonary capillary bed.
- Trial name
- NCT01971580
- Testing
- Ambrisentan
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Washington University School of Medicine
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
Thrombosis
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8…
- Trial name
- UNIVERSE (NCT02846532)
- Testing
- Rivaroxaban, Acetylsalicylic Acid
- Where
- 42 sites in United States, Argentina and 8 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC