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REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
NCT06150950 · Stanford University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure
About this study
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 failure. Eligible study subjects will be identified from clinical chart review and study informational fliers will be sent to Adult Congenital Heart Disease (ACHD) cardiologists at all centers. Fontan failure patients being evaluated for outpatient care at ACHD centers and meeting eligibility criteria will be enrolled and randomly assigned to either cardiac rehabilitation or usual clinical 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%
Study design
Enrollment target: 50 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-05-05
Estimated completion: 2026-12-31
Last updated: 2026-01-05
Interventions
Behavioral: Cardiac rehabilitationOther: Usual care
Primary outcomes
- • Average daily step count (120 days (+/- 45 days) post-randomization)
Sponsor
Stanford University · other
With: Vanderbilt University Medical Center, Adult Congenital Heart Association, Julie Fletcher Memorial Fund, Pete Huttlinger Memorial Fund
Contacts & investigators
InvestigatorDaniel E Clark, MD, MPH · principal_investigator, Stanford University
InvestigatorJonathan N Menachem, MD · principal_investigator, Vanderbilt University Medical Center
All locations (2)
Stanford UniversityRecruiting
Stanford, California, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States