NCT06150950NARecruiting

REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

Stanford University

Start Date

5/5/2024

Completion Date

12/31/2026

Summary

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?

Detailed Description

REHAB Fontan Failure is a a multi-center, non-blinded, randomized clinical trial evaluating the effect of cardiac rehabilitation compared to usual care on exercise tolerance among adults with Fontan failure. Eligible study subjects will be identified from clinical chart review and study informational fliers will be sent to Adult Congenital Heart Disease (ACHD) cardiologists at all centers. Fontan failure patients being evaluated for outpatient care at ACHD centers and meeting eligibility criteria will be enrolled and randomly assigned to either cardiac rehabilitation or usual clinical care.

Eligibility Criteria

Age Range: 18 years to No maximum

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%

Interventions

BEHAVIORAL

Cardiac rehabilitation

OTHER

Usual care

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Conditions

Heart Failure CongenitalSingle-ventricle

Locations

Stanford University

Stanford, California 94305

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37240

United States