REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

Single-ventricle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150950
• Other study ID #: 67788
• Status: Recruiting
• Phase: N/A
• 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
• 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%

Related Conditions & MeSH terms

• Single-ventricle
• Univentricular Heart

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