Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06150950

REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

Led by Stanford University · Updated on 2026-01-05

50

Participants Needed

2

Research Sites

138 weeks

Total Duration

On this page

Sponsors

S

Stanford University

Lead Sponsor

V

Vanderbilt University Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of Fontan procedure and at least one of the following: systemic ventricular EF less than 50% by imaging, protein losing enteropathy, plastic bronchitis, chronic loop diuretics prescribed by an Adult Congenital Heart Disease cardiologist, or peak VO2 less than 50% predicted
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Inotrope dependence
  • Symptomatic, uncontrolled arrhythmias
  • Pregnancy
  • Contraindication to cardiac rehabilitation or current enrollment in cardiac rehabilitation
  • Inability to comply with the study protocol
  • Planned Fontan pathway percutaneous or surgical intervention within the last 3 months
  • Resting oxygen saturation less than 80% indicating hypoxemia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Stanford University

Stanford, California, United States, 94305

Actively Recruiting

2

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37240

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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REHAB Fontan Failure: A Trial of Cardiac Rehabilitation | DecenTrialz