Status:
RECRUITING
REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Vanderbilt University Medical Center
Adult Congenital Heart Association
Conditions:
Heart Failure Congenital
Single-ventricle
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 failur...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
May 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06150950
Start Date
May 5 2024
End Date
December 31 2026
Last Update
January 5 2026
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University
Stanford, California, United States, 94305
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37240