Re-Energize Fontan

  • End date
    Jan 6, 2025
  • participants needed
  • sponsor
    Stanford University
Updated on 7 October 2022


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.

Condition Single-ventricle
Treatment Live-Video-Supervised Exercise Intervention, Usual Care then Live-Video Supervised Exercise Intervention
Clinical Study IdentifierNCT04195451
SponsorStanford University
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

-19 years of age
Fontan palliation
Ability to fast overnight
Cardiac clearance to exercise by primary cardiologist
Presence of an adult at home during exercise sessions for patients <14 years old
English-speaking patient

Exclusion Criteria

NYHA Class IV (severe heart failure)
Acute illness within the past three months
Active protein losing enteropathy (albumin <2.5 mg/dL)
Implanted pacemaker
Cognitive delay deemed severe enough to inhibit the ability to follow the exercise
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