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REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Fontan failure, defined as history of a Fontan procedure and at least one of the following: systemic ventricular EF \<50% (by echocardiography, cardiac magnetic resonance imaging, or computer tomography), protein losing enteropathy, plastic bronchitis, chronic loop diuretics prescribed by ACHD Cardiologist, and/or peak VO2 \< 50% predicted (by FRIEND equation) * Age \>= 18 years old Exclusion Criteria: * Inotrope-dependence * Symptomatic, uncontrolled arrhythmias * Pregnancy * Contraindication to cardiac rehab or already enrolled in cardiac rehabilitation * Inability to comply with the protocol * Recent (\<3 months) planned Fontan pathway percutaneous or surgical intervention * Resting hypoxemia with baseline oxygen saturation \<80%
About the study
The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life.
1. Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care? 2. Among patients with Fontan failure, will cardiac rehabilitation improve exertional tolerance (as measured by cardiopulmonary exercise testing), frailty, and self-reported quality of life metrics compared to usual care?
What is being tested
- Cardiac rehabilitation (behavioral)
- Usual care (other)
Sponsor: Stanford University · Participants: 50 · Started: May 5, 2024
Contact the study team
Official record on ClinicalTrials.gov — NCT06150950
Locations in the U.S.
| California | Stanford University, Stanford |
| Tennessee | Vanderbilt University Medical Center, Nashville |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.