REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

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?

Conditions

• Heart Failure Congenital
• Single-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.

Sponsors & Collaborators

• Vanderbilt University Medical Center

  collaborator OTHER

• Adult Congenital Heart Association

  collaborator UNKNOWN

• Julie Fletcher Memorial Fund

  collaborator UNKNOWN

• Pete Huttlinger Memorial Fund

  collaborator UNKNOWN

• Stanford University

  lead OTHER

Principal Investigators

• Daniel E Clark, MD, MPH · Stanford University

• Jonathan N Menachem, MD · Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-05

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United States

Study Locations