REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac rehabilitation, Usual care.
- Who it may be relevant to
- Registry conditions: Heart Failure Congenital, Single-ventricle. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure
Overview
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?
Detailed description
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.
Interventions
- Behavioral Cardiac rehabilitation
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 cardi - Other Usual care
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.
Primary outcome measures
- Average daily step count [Time frame: 120 days (+/- 45 days) post-randomization]
Secondary outcome measures (12)
- Change in 5-meter timed walk as a measure of slowness [Time frame: Baseline and 120 days (+/- 45 days) post-randomization]
- Change in exercise time as a measure of exhaustion [Time frame: Baseline and 120 days (+/- 45 days) post-randomization]
- Change in respiratory exchange ratio (RER) as a measure of exhaustion [Time frame: Baseline and 120 days (+/- 45 days) post-randomization]
- Change in mini-nutritional assessment short form (MNA-SF) score [Time frame: Baseline and 120 days (+/- 45 days) post-randomization]
- Change in body fat percentage [Time frame: Baseline and 120 days (+/- 45 days) post-randomization]
- Change in grip strength [Time frame: Baseline and 120 days (+/- 45 days) post-randomization]
- Change in patient reported physical activity questionnaire score [Time frame: Baseline and 120 days (+/- 45 days) post-randomization]
- Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) scale score [Time frame: Baseline and 120 days (+/- 45 days) post-randomization]
- Change Patient Health Questionnaire-2 (PHQ-2) score [Time frame: Baseline and 120 days (+/- 45 days) post-randomization]
- Average daily active minutes [Time frame: Baseline and 120 days (+/- 45 days) post-randomization]
- Average daily active minutes of moderate-high intensity activity [Time frame: Baseline and 120 days (+/- 45 days) post-randomization]
- Average daily sedentary minutes [Time frame: Baseline and 120 days (+/- 45 days) post-randomization]
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%
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Stanford University — Stanford
- Vanderbilt University Medical Center — Nashville
Identifiers
NCT: NCT06150950 · 67788