©2025 Stanford Medicine
REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
Recruiting
I'm InterestedTrial ID: NCT06150950
Purpose
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?
Official Title
RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure
Stanford Investigator(s)
Daniel Clark, MD, MPH
Clinical Assistant Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology
Eligibility
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%
Intervention(s):
behavioral: Cardiac rehabilitation
other: Usual care
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
DANIEL CLARK, MD, MPH
650-724-9220