NCT06150950 REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
| NCT ID | NCT06150950 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Heart Failure Congenital |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-05-05 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-05-05 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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?
Eligibility 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%
Contact & Investigator
Daniel E Clark, MD, MPH
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT06150950 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure Congenital. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06150950 currently recruiting?
Yes, NCT06150950 is actively recruiting participants. Visit ClinicalTrials.gov or contact Stanford University to inquire about joining.
Where is the NCT06150950 trial being conducted?
This trial is being conducted at Stanford, United States, Nashville, United States.
Who is sponsoring the NCT06150950 clinical trial?
NCT06150950 is sponsored by Stanford University. The principal investigator is Daniel E Clark, MD, MPH at Stanford University. The trial plans to enroll 50 participants.
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