Actively Recruiting
REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
Led by Stanford University · Updated on 2026-01-05
50
Participants Needed
2
Research Sites
138 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
V
Vanderbilt University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of Fontan procedure and at least one of the following: systemic ventricular EF less than 50% by imaging, protein losing enteropathy, plastic bronchitis, chronic loop diuretics prescribed by an Adult Congenital Heart Disease cardiologist, or peak VO2 less than 50% predicted
- Age 18 years or older
You will not qualify if you...
- Inotrope dependence
- Symptomatic, uncontrolled arrhythmias
- Pregnancy
- Contraindication to cardiac rehabilitation or current enrollment in cardiac rehabilitation
- Inability to comply with the study protocol
- Planned Fontan pathway percutaneous or surgical intervention within the last 3 months
- Resting oxygen saturation less than 80% indicating hypoxemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37240
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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