REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
Recruiting · NCT06150950 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Cardiac rehabilitationUsual care
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?
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed across 2 US states.
- Stanford University - Stanford, California, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States