NCT06150950Recruiting
REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure
Source: ClinicalTrials.gov · Last updated 5 Jan 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 30 May 2023
- Start date
- 5 May 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Stanford University
- Diseases
- Heart failure
- NCT number
- NCT06150950
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 5 May 2024 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent (\<3 months) planned Fontan pathway percutaneous or surgical intervention
Other illness
- Symptomatic, uncontrolled arrhythmias
- Contraindication to cardiac rehab or already enrolled in cardiac rehabilitation
Other
- Inotrope-dependence
- Pregnancy
- Inability to comply with the protocol
- Resting hypoxemia with baseline oxygen saturation \<80%
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.