REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Single-ventricle; Heart Failure Congenital
• Intervention / Treatment: Behavioral: Cardiac rehabilitation; Other: 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Tennessee
    • Nashville, Tennessee, United States, 37240
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac rehabilitation; For patient randomized to cardiac rehabilitation, the ACHD clinician will place the referral after they and the patient have seen the group assignment. All participants will be referred to Heart Fit for Life community-based cardiac rehabilitation program in Palo Alto, CA. Cardiac rehabilitation will be offered as an in-person, hybrid, or completely virtual program for Stanford participants and will be entirely virtual for Vanderbilt participants. Participants will attend 3 sessions per week for 12 weeks. Participants will receive weekly email reminders via the electronic medical record to encourage participation. The study protocol pertains only to referral to cardiac rehabilitation. All other aspects of the cardiac care will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking.	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.
Active Comparator: Usual care; For patients 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. All study participants will receive a Fitbit for daily activity tracking.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 5-meter timed walk as a measure of slowness		Baseline and 120 days (+/- 45 days) post-randomization
Change in exercise time as a measure of exhaustion	Exercise time on cardiopulmonary exercise testing	Baseline and 120 days (+/- 45 days) post-randomization
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
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
Change in body fat percentage	Body fat percentage is a measure of body composition	Baseline and 120 days (+/- 45 days) post-randomization
Change in grip strength		Baseline and 120 days (+/- 45 days) post-randomization
Change in patient reported physical activity questionnaire score		Baseline and 120 days (+/- 45 days) post-randomization
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
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
Average daily active minutes	Total average daily active minutes from Fitbit	Baseline and 120 days (+/- 45 days) post-randomization
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
Average daily sedentary minutes	Average daily sedentary minutes from Fitbit	Baseline and 120 days (+/- 45 days) post-randomization
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
Change in oxygen (O2) pulse	O2 pulse on follow-up cardiopulmonary exercise testing, adjusted for baseline	Baseline and 120 days (+/- 45 days) post-randomization
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
Change in anaerobic threshold	Anaerobic threshold on follow-up cardiopulmonary exercise testing, adjusted for baseline	Baseline and 120 days (+/- 45 days) post-randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Vanderbilt University Medical Center; Adult Congenital Heart Association; Julie Fletcher Memorial Fund; Pete Huttlinger Memorial Fund
• Investigators: Principal Investigator: Daniel E Clark, MD, MPH, Stanford University; Principal Investigator: Jonathan N Menachem, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): November 28, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac rehabilitation; Fontan; Single ventricle
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Univentricular Heart
• Other Study ID Numbers: 67788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No