RECRUITING

REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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?

Official Title

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

Quick Facts

Study Start:2024-05-05
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06150950

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Age \>= 18 years old
  1. * Inotrope-dependence
  2. * Symptomatic, uncontrolled arrhythmias
  3. * Pregnancy
  4. * Contraindication to cardiac rehab or already enrolled in cardiac rehabilitation
  5. * Inability to comply with the protocol
  6. * Recent (\<3 months) planned Fontan pathway percutaneous or surgical intervention
  7. * Resting hypoxemia with baseline oxygen saturation \<80%

Contacts and Locations

Principal Investigator

Daniel E Clark, MD, MPH
PRINCIPAL_INVESTIGATOR
Stanford University
Jonathan N Menachem, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Stanford University
Stanford, California, 94305
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37240
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Daniel E Clark, MD, MPH, PRINCIPAL_INVESTIGATOR, Stanford University
  • Jonathan N Menachem, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-05
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-05-05
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Fontan
  • Single ventricle
  • Cardiac rehabilitation

Additional Relevant MeSH Terms

  • Heart Failure Congenital
  • Single-ventricle