REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

NCT ID: NCT06150950

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-05
• Study Completion Date: 2026-12-31

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.

Conditions

Heart Failure Congenital; Single-ventricle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cardiac rehabilitation

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Vanderbilt University Medical Center

OTHER

Sponsor Role: collaborator

Adult Congenital Heart Association

UNKNOWN

Sponsor Role: collaborator

Julie Fletcher Memorial Fund

UNKNOWN

Sponsor Role: collaborator

Pete Huttlinger Memorial Fund

UNKNOWN

Sponsor Role: collaborator

Responsible Party

Daniel Clark

Assistant Professor of Adult and Pediatric Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel E Clark, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Jonathan N Menachem, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Stanford University

Stanford, California, United States

Site Status: RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

DANIEL CLARK, MD, MPH

Role: primary

danclark@stanford.edu

650-724-9220

Jonathan Menachem, MD

Role: primary

"Jonathan Menachem" <jonathan.n.menachem@vumc.org>

615-322-2318

Other Identifiers

67788

Identifier Type: -

Identifier Source: org_study_id