What this study is
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?
What's being tested
- Cardiac rehabilitation
Intervention · BEHAVIORAL
Cardiac rehabilitation is a multifaceted, comprehensive therapeutic intervention of personalized, supervised exercise training that is beneficial and well-studied among patients with non-ACHD heart failure and has consistently been shown to improve QOL. Unfortunately, cardiac rehabilitation has been underutilized with an overall participation <50% of eligible patients despite international guidelines advocating for more consistent deployment of cardiac rehabilitation. A major a barrier to cardiac rehabilitation is access, as CMS-mandates a physician be within 3 minutes of the rehabilitation facility to assure insurance reimbursement. This mandate limits isolated, outpatient cardiac rehabilitation programs, especially in rural communities.
- Usual care
Intervention · OTHER
For participants randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians.
Study details
- Official title
- RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure
- Sponsor
- Stanford University
- Conditions
- Heart Failure Congenital · Single-ventricle
- Enrolling
- 50 people
- Starts
- 2024-05-05
- Est. completion
- 2026-12-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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%
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openStanford University
Stanford, California, United States
- DANIEL CLARK, MD, MPH · Contact650-724-9220danclark@stanford.edu
RecruitingVanderbilt University Medical Center
Nashville, Tennessee, United States
- Jonathan Menachem, MD · Contact615-322-2318"Jonathan Menachem" <jonathan.n.menachem@vumc.org>
Recruiting
Study team
Sponsor
Stanford University
Study ID 67788
Principal investigator
Daniel E Clark, MD, MPH
Stanford University
Principal investigator
Jonathan N Menachem, MD
Vanderbilt University Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.