Re-Energize Fontan

Single-ventricle Clinical Trial

Official title:

RE-ENERGIZE FONTAN: A RandomizEd Exercise INtERvention DesiGned to MaximIZE Fitness in Pediatric FONTAN Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04195451
• Other study ID #: 46606
• Secondary ID: R33HL1467751R61H
• Status: Recruiting
• Phase: N/A
• Start date: August 6, 2020
• Est. completion date: January 6, 2025

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: Seda Tierney
• Phone: 650-334-7156
• Email: tierneys[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 6, 2025
• Est. primary completion date: October 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 19 Years

Eligibility

Inclusion Criteria:

• 8-19 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

Related Conditions & MeSH terms

• Single-ventricle
• Univentricular Heart

Intervention

Other:
• Live-Video-Supervised Exercise Intervention
The live-video-supervised exercise intervention includes exercise sessions x3/week for 3 months, and then maintenance regimen for 6 months. Maintenance includes live-video-supervised exercise sessions, only x1/week, and self-exercise x2/week following an individualized prescribed exercise program and use their heart rate monitor as an activity tracker.
• Usual Care then Live-Video Supervised Exercise Intervention
Patients randomized to usual care at baseline will receive usual care for 9 months and will then start the live-video-supervised exercise intervention that includes exercise sessions x3/week for 3 months.

Locations

Country	Name	City	State
United States	Stanford University, Lucile Packard Children Hospital	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	National Heart, Lung, and Blood Institute (NHLBI), The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in volume of Oxygen Consumed at Maximal Exertion	In Fontan patients, peak VO2 is a powerful predictor of poor outcomes. The subjects will undergo progressive cardiopulmonary exercise testing with continuous monitoring by 12-lead EKG and gas exchange by measuring breath-to-breath ventilation. Exercise capacity will be measured by a cardiopulmonary exercise test to obtain the peak VO2	Baseline, 3 months, 9 months, 12 months