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Behavioral Intervention

Cardiac Rehabilitation for Congenital Heart Failure

N/A
Recruiting
Led By Jonathan N Menachem, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Recent (<3 months) planned Fontan pathway percutaneous or surgical intervention
Inotrope-dependence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 days (+/- 45 days) post-randomization
Awards & highlights

Summary

This trial tests if cardiac rehab helps Fontan failure patients feel better & be more active.

Who is the study for?
This trial is for adults over 18 with Fontan failure, which means they've had a specific heart surgery and have issues like low heart pump function or need chronic diuretics. It's not for those dependent on drugs to support heart contractions, uncontrolled irregular heartbeats, pregnant women, current cardiac rehab patients, or those planning another heart procedure soon.
What is being tested?
The study aims to see if a special exercise and education program (cardiac rehabilitation) can help people with Fontan failure walk more steps daily and improve their exercise capacity, frailty level, and life quality compared to usual care without this program.
What are the potential side effects?
Cardiac rehabilitation generally includes safe exercises tailored to each person's needs. However, some may experience fatigue or muscle soreness initially as they adjust to the new activity levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a Fontan procedure and suffer from heart or lung issues, or need chronic medication for fluid buildup.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a recent Fontan procedure.
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I need medication to help my heart pump better.
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I have heart rhythm problems that are not under control and cause symptoms.
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I cannot participate in or am already enrolled in cardiac rehab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 120 days (+/- 45 days) post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 120 days (+/- 45 days) post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average daily step count
Secondary outcome measures
Average daily active minutes
Average daily active minutes of moderate-high intensity activity
Average daily sedentary minutes
+11 more
Other outcome measures
Exploratory outcome: number of participants with exercise-induced clinical ailment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cardiac rehabilitationExperimental Treatment1 Intervention
For patient randomized to cardiac rehabilitation, the ACHD clinician will place the referral after they and the patient have seen the group assignment. All participants will be referred to Heart Fit for Life community-based cardiac rehabilitation program in Palo Alto, CA. Cardiac rehabilitation will be offered as an in-person, hybrid, or completely virtual program for Stanford participants and will be entirely virtual for Vanderbilt participants. Participants will attend 3 sessions per week for 12 weeks. Participants will receive weekly email reminders via the electronic medical record to encourage participation. The study protocol pertains only to referral to cardiac rehabilitation. All other aspects of the cardiac care will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking.
Group II: Usual careActive Control1 Intervention
For patients randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cardiac rehabilitation
2006
Completed Phase 3
~910

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,393 Total Patients Enrolled
Julie Fletcher Memorial FundUNKNOWN
Vanderbilt University Medical CenterOTHER
888 Previous Clinical Trials
934,884 Total Patients Enrolled
~33 spots leftby Dec 2025
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