Cardiac rehabilitation for patients with Fontan failure
RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure
This study tests if a cardiac rehabilitation program can help adults with Fontan failure feel better and improve their daily activities compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 2 sites (Stanford, California and 1 other locations) |
| Trial ID | NCT06150950 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of cardiac rehabilitation on adults with Fontan failure, focusing on improvements in exertional tolerance, frailty, and quality of life. Participants will be randomly assigned to either a cardiac rehabilitation program or receive usual clinical care. The study aims to measure outcomes such as average daily steps, exercise tolerance through cardiopulmonary testing, and self-reported quality of life metrics. The trial will involve multiple centers and will identify eligible patients through clinical chart reviews and outreach to cardiologists.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of Fontan procedure and specific clinical indicators of Fontan failure.
Not a fit: Patients who are inotrope-dependent, have uncontrolled arrhythmias, or are unable to comply with the rehabilitation protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could significantly enhance the quality of life and physical capabilities of patients with Fontan failure.
How similar studies have performed: Previous studies have shown promising results for cardiac rehabilitation in heart failure populations, suggesting potential success for this approach in Fontan failure patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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%
Where this trial is running
Stanford, California and 1 other locations
- Stanford University — Stanford, California, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Daniel E Clark, MD, MPH — Stanford University
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.