NCT06150950 · Stanford University
REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Stanford, California
- Nashville, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 5, 2026 · Source of record for eligibility and locations