Cardiac rehabilitation for patients with Fontan failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effects of cardiac rehabilitation on adults with Fontan failure, focusing on improvements in exertional tolerance, frailty, and quality of life. Participants will be randomly assigned to either a cardiac rehabilitation program or receive usual clinical care. The study aims to measure outcomes such as average daily steps, exercise tolerance through cardiopulmonary testing, and self-reported quality of life metrics. The trial will involve multiple centers and will identify eligible patients through clinical chart reviews and outreach to cardiologists.

Why it matters

Who can join: the full rules

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%

Where it's running

• Stanford University
  Stanford, California, United States Recruiting
• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Daniel E Clark, MD, MPH — Stanford University

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.