REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 5, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Heart Failure CongenitalSingle-ventricle
Interventions
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.

Trial Locations (2)

37240

RECRUITING

Vanderbilt University Medical Center, Nashville

94305

RECRUITING

Stanford University, Stanford

All Listed Sponsors
collaborator

Vanderbilt University Medical Center

OTHER

collaborator

Adult Congenital Heart Association

UNKNOWN

collaborator

Julie Fletcher Memorial Fund

UNKNOWN

collaborator

Pete Huttlinger Memorial Fund

UNKNOWN

lead

Stanford University

OTHER