Clinical trial NCT06150950: REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
Official title: RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure Congenital
Single-ventricle
Keywords: Fontan
Single ventricle
Cardiac rehabilitation
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
name: Adult Congenital Heart Association
name: Julie Fletcher Memorial Fund
name: Pete Huttlinger Memorial Fund
First posted: 2023-11-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At enrollment, participants will be randomized in a 1:1 ratio to cardiac rehabilitation or usual care using randomly permuted blocks of 2, 4, and 6. The randomization will be stratified by study site and time from Fontan palliation.
Primary purpose: TREATMENT

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?

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.

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%

Primary outcomes:
measure: Average daily step count
timeFrame: 120 days (+/- 45 days) post-randomization
Secondary outcomes:
measure: Change in 5-meter timed walk as a measure of slowness
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
measure: Change in exercise time as a measure of exhaustion
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
measure: Change in respiratory exchange ratio (RER) as a measure of exhaustion
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
measure: Change in mini-nutritional assessment short form (MNA-SF) score
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
measure: Change in body fat percentage
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
measure: Change in grip strength
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
measure: Change in patient reported physical activity questionnaire score
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
measure: Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) scale score
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
measure: Change Patient Health Questionnaire-2 (PHQ-2) score
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
measure: Average daily active minutes
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
measure: Average daily active minutes of moderate-high intensity activity
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
measure: Average daily sedentary minutes
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
measure: Change in peak respiratory oxygen uptake (VO2)
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
measure: Change in oxygen (O2) pulse
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
measure: Change in minute ventilation/carbon dioxide production (VE/VCO2)
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
measure: Change in anaerobic threshold
timeFrame: Baseline and 120 days (+/- 45 days) post-randomization
Other outcomes:
measure: Exploratory outcome: number of participants with exercise-induced clinical ailment
timeFrame: 120 days (+/- 45 days) post-randomization
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Stanford University
name: Daniel E Clark, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Jonathan N Menachem, MD
role: PRINCIPAL_INVESTIGATOR
References: