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Cardiac Rehabilitation for Fontan Failure

This study is looking at whether cardiac rehabilitation can help adults who have Fontan failure (a complication after a specific heart surgery for single-ventricle heart disease). Cardiac rehabilitation involves personalized, supervised exercise training. Researchers want to see if this program can improve your daily step count, how well you can exercise, your overall physical weakness (frailty), and your quality of life, compared to receiving usual medical care. You might be able to join if you are 18 or older and have Fontan failure, which means you've had a Fontan procedure and have certain heart issues like a weakened heart or other specific health problems. The study aims to enroll 50 participants, but its current status (whether it's actively recruiting) is unclear.

Study design
This is a multi-center, randomized study where participants will be assigned by chance to either receive cardiac rehabilitation or usual care. The study plans to enroll 50 adult participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your average daily step count will be measured around 120 days (+/- 45 days) after you are assigned to a group.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06150950

REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

Recruiting
NAAges 18+InterventionalTreatment
Stanford University
~50 participants
Updated 2026-01-05 on ClinicalTrials.gov
What's tested:Cardiac rehabilitationUsual care

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average daily step count
Measured over 120 days (+/- 45 days) post-randomization

Conditions

Heart Failure Congenital
Single-ventricle

Explore related trials

Common Ventricle DisorderHeart Failure

Where it's being run

2 sites across 2 states
California1
Tennessee1

Study leadership

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

Who to contact

DANIEL CLARK, MD, MPH
[email protected]
650-724-9220
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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%

What this trial measures

  • Average daily step count120 days (+/- 45 days) post-randomization

    Average daily step count during the intervention period measured by Fitbit 3 activity tracker