Re-Energize Fontan

Status Recruiting

Clinical Trial Summary

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. By the age of 40, 50% of Fontan patients will have died or undergone heart transplantation. With >1,000 Fontan palliations performed in the US annually, there is a burgeoning population of Fontan patients at risk for progressive heart failure and death. Factors that contribute to onset and progression of heart failure in Fontan patients remain incompletely understood. However, it is established that Fontan patients have poor exercise capacity, associated with a greater risk of morbidity and mortality, in addition to decreased muscle mass, abnormal muscle function, and endothelial dysfunction contributing to disease progression. In adult patients with two ventricles and heart failure, reduced exercise capacity, muscle mass, and muscle strength are powerful predictors of poor outcomes, and exercise interventions can not only improve exercise capacity and muscle mass, but also reverse endothelial dysfunction. Limited exercise interventions in children with congenital heart disease have demonstrated that exercise is safe and effective; however, these studies have been conducted in small, heterogeneous groups, and most had few Fontan patients. Furthermore, none of these interventions have studied the impact of exercise on muscle mass or mitochondrial function, or endothelial function. The investigators propose a milestone-driven, randomized controlled trial in pediatric Fontan patients to test the hypothesis that a live-video-supervised exercise (aerobic + resistance) intervention will improve cardiac and physical capacity; muscle mass, strength and function; and endothelial function. The investigators' ultimate goal is the translation of this model to clinical application as an "exercise prescription" to intervene early in pediatric Fontan patients and decrease long-term morbidity and mortality.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04195451
Study type	Interventional
Source	Stanford University
Contact	Seda Tierney
Phone	650-334-7156
Email	tierneys@stanford.edu
Status	Recruiting
Phase	N/A
Start date	August 6, 2020
Completion date	January 6, 2025

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See also
Status	Clinical Trial	Phase
Completed	`NCT03119090` - Fontan Imaging Biomarkers (FIB) Study
Completed	`NCT05063903` - Exercise Capacity in Patients With Fontan Procedure
Not yet recruiting	`NCT04017494` - Validation of Cardiac Magnetic Resonance Sequences in Patients With Single Ventricles
Recruiting	`NCT04106479` - NIRS in Congenital Heart Defects - Correlation With Echocardiography
Recruiting	`NCT06150950` - REHAB Fontan Failure: A Trial of Cardiac Rehabilitation	N/A
Completed	`NCT03481985` - The Effect of Fontan Fenestration Closure on Hepatic Stiffness
Completed	`NCT03088345` - Early Use of Vasopressin in Post-Fontan Management	Phase 2/Phase 3
Completed	`NCT03470428` - Clinical Characteristics and Associations of the "Good Fontan" Patient
Completed	`NCT04956952` - Enhanced External Counterpulsation in Patients With Fontan Circulation	N/A
Completed	`NCT04785482` - The PaTHS Descriptive Correlational Longitudinal Study
Not yet recruiting	`NCT06434207` - Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
Withdrawn	`NCT03997097` - Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease	Phase 3
Completed	`NCT05118152` - Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle
Recruiting	`NCT05262907` - Ventripoint Single Ventricle Study	N/A
Withdrawn	`NCT01149603` - The Destination Therapy Evaluation for Failing Fontan Study	N/A
Recruiting	`NCT04467671` - Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts	Phase 2
Completed	`NCT03339466` - Inspiratory Muscle Therapy in Subjects With Fontan Circulations	N/A
Completed	`NCT05011565` - Hemodynamic, Vascular and Muscular Parameters of Exercise Capacity in Single-Ventricle Patients With Fontan Procedure
Active, not recruiting	`NCT03263312` - Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient	N/A
Recruiting	`NCT05034354` - Virtual Remote Physiological Monitoring Program of Children With Heart Disease	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.