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Exercise for Single Ventricle Heart

N/A
Waitlist Available
Research Sponsored by Maria Bano
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current age 10 years to 40 years
Presence of a congenital heart defect that leads to single ventricle physiology
Must not have
Unstable arrhythmia at the time of screening
Patient with pacemaker, AV block other than 1st degree block, sick sinus syndrome or other arrhythmia that may influence ability to perform exercise test or magnetic resonance imaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will enroll 50 Fontan patients and 20 control subjects to study the effects of exercise on the Fontan circulation.

Who is the study for?
This trial is for individuals aged 10-40 with a congenital heart defect leading to single ventricle physiology who've had TCPA surgery. They must be able to give informed consent. It's not for pregnant or breastfeeding individuals, those with pacemakers, certain heart blocks or arrhythmias, exercise intolerance, unstable arrhythmia at screening time, or those listed for heart transplantation.
What is being tested?
The study tests how exercise affects Fontan patients by using MRI scans of the heart, lung and liver before and after a 3-6 month cardiac rehab program. Blood tests will also measure biomarkers and microRNAs related to their condition.
What are the potential side effects?
Since this trial involves an exercise program rather than medication, side effects may include typical risks associated with physical activity such as muscle soreness or strain but should be minimal under supervised conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 10 and 40 years old.
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I was born with a heart defect that results in having only one working heart chamber.
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I have had TCPA surgery before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have an irregular heartbeat that is currently uncontrolled.
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I have a heart condition that could affect exercise tests or MRI scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Peak VO2

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fontan PatientsExperimental Treatment1 Intervention
All Fontan patients included in this study will be part of an exercise intervention 2-6 times/week for 3-6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~820

Find a Location

Who is running the clinical trial?

Maria BanoLead Sponsor

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT03263312 — N/A
Single Ventricle Heart Research Study Groups: Fontan Patients
Single Ventricle Heart Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT03263312 — N/A
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT03263312 — N/A
~3 spots leftby Jun 2025
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