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REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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?

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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%

Study sites (2)

CA

TN