REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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?
Eligibility criteria
Qualifiers
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
Disqualifiers
Inotrope-dependence
Symptomatic, uncontrolled arrhythmias
Pregnancy
Contraindication to cardiac rehab or already enrolled in cardiac rehabilitation
Trial design
Treatments tested in this trial
- Cardiac rehabilitation
- Usual care
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Stanford University
Lead sponsor
Vanderbilt University Medical Center
Collaborator
Adult Congenital Heart Association
Collaborator
Julie Fletcher Memorial Fund
Collaborator
Pete Huttlinger Memorial Fund
Collaborator
Source ClinicalTrials.gov