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REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

RECRUITINGN/ASponsored by Stanford University
Actively Recruiting
PhaseN/A
SponsorStanford University
Started2024-05-05
Est. completion2026-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites

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?

Eligibility

Age: 18 Years+Healthy volunteers accepted
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%

Conditions3

Heart DiseaseHeart Failure CongenitalSingle-ventricle

Locations2 sites

California

1 site
Stanford University
Stanford, California, 94305
DANIEL CLARK, MD, MPH650-724-9220danclark@stanford.edu

Tennessee

1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37240

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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