REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

NCT06150950 | Recruiting

• 1 other identifier: 67788
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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. 1.Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care?
2. 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?

Conditions

Heart Failure Congenital; Single-ventricle

Keywords

Fontan; Single ventricle; Cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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

  Baseline and 120 days (+/- 45 days) post-randomization

• Change in respiratory exchange ratio (RER) as a measure of exhaustion

  Baseline and 120 days (+/- 45 days) post-randomization

• Change in mini-nutritional assessment short form (MNA-SF) score

  Baseline and 120 days (+/- 45 days) post-randomization

• Change in body fat percentage

  Baseline and 120 days (+/- 45 days) post-randomization

Other Outcomes (1)

• Exploratory outcome: number of participants with exercise-induced clinical ailment

  120 days (+/- 45 days) post-randomization

Study Arms (2)

Cardiac rehabilitation

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

Cardiac rehabilitation BEHAVIORAL

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.

Cardiac rehabilitation

Usual care OTHER

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.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Stanford University: lead
• Vanderbilt University Medical Center: collaborator
• Adult Congenital Heart Association: collaborator
• Julie Fletcher Memorial Fund: collaborator
• Pete Huttlinger Memorial Fund: collaborator

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37240, United States

RECRUITING

MeSH Terms

Conditions

Univentricular Heart

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Daniel E Clark, MD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

• Jonathan N Menachem, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Adult and Pediatric Cardiology

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: November 30, 2023
• Study Start: May 5, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)