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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06150950
Other study ID # 67788
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 5, 2024
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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 cardiac rehabilitation is access, as CMS-mandates a physician be within 3 minutes of the rehabilitation facility to assure insurance reimbursement. This mandate limits isolated, outpatient cardiac rehabilitation programs, especially in rural communities.
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.

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee
United States Stanford University Stanford California

Sponsors (5)

Lead Sponsor Collaborator
Stanford University Adult Congenital Heart Association, Julie Fletcher Memorial Fund, Pete Huttlinger Memorial Fund, Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Exploratory outcome: number of participants with exercise-induced clinical ailment Sustained arrhythmia or hemodynamic change necessitating hospitalization, heart failure hospitalization, or all-cause death within 30 days of completion of cardiac rehabilitation 120 days (+/- 45 days) post-randomization
Primary Average daily step count Average daily step count during the intervention period measured by Fitbit 3 activity tracker 120 days (+/- 45 days) post-randomization
Secondary Change in 5-meter timed walk as a measure of slowness Baseline and 120 days (+/- 45 days) post-randomization
Secondary Change in exercise time as a measure of exhaustion Exercise time on cardiopulmonary exercise testing Baseline and 120 days (+/- 45 days) post-randomization
Secondary Change in respiratory exchange ratio (RER) as a measure of exhaustion RER on cardiopulmonary exercise testing (exhaustion) Baseline and 120 days (+/- 45 days) post-randomization
Secondary Change in mini-nutritional assessment short form (MNA-SF) score Nutrition score as measured by MNA-SF; range 0-14; malnourished 0-7, 8-11 at-risk, and 12-14 normal nutritional status Baseline and 120 days (+/- 45 days) post-randomization
Secondary Change in body fat percentage Body fat percentage is a measure of body composition Baseline and 120 days (+/- 45 days) post-randomization
Secondary Change in grip strength Baseline and 120 days (+/- 45 days) post-randomization
Secondary Change in patient reported physical activity questionnaire score The physical activity questionnaire score ranges from 0 - 10,000 kilo-calories/week, with higher scores representing higher physical activity. Baseline and 120 days (+/- 45 days) post-randomization
Secondary Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) scale score KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks. The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status. A positive change from baseline indicates improvement. Baseline and 120 days (+/- 45 days) post-randomization
Secondary Change Patient Health Questionnaire-2 (PHQ-2) score Mood assessment (Range 0-6, higher score indicates higher risk of depression, >=3 suggestive of depression) Baseline and 120 days (+/- 45 days) post-randomization
Secondary Average daily active minutes Total average daily active minutes from Fitbit Baseline and 120 days (+/- 45 days) post-randomization
Secondary Average daily active minutes of moderate-high intensity activity Average daily active minutes of moderate-high intensity activity from Fitbit Baseline and 120 days (+/- 45 days) post-randomization
Secondary Average daily sedentary minutes Average daily sedentary minutes from Fitbit Baseline and 120 days (+/- 45 days) post-randomization
Secondary Change in peak respiratory oxygen uptake (VO2) Peak VO2 on follow-up cardiopulmonary exercise testing, adjusted for baseline Baseline and 120 days (+/- 45 days) post-randomization
Secondary Change in oxygen (O2) pulse O2 pulse on follow-up cardiopulmonary exercise testing, adjusted for baseline Baseline and 120 days (+/- 45 days) post-randomization
Secondary Change in minute ventilation/carbon dioxide production (VE/VCO2) VE/VCO2 on follow-up cardiopulmonary exercise testing, adjusted for baseline Baseline and 120 days (+/- 45 days) post-randomization
Secondary Change in anaerobic threshold Anaerobic threshold on follow-up cardiopulmonary exercise testing, adjusted for baseline Baseline and 120 days (+/- 45 days) post-randomization
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