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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Peak VO2

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

~760

0 / 3Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I qualified to participate in this experiment?

"The requirements to be accepted into this life-saving trial are that applicants have a single ventricle heart and fall between the age range of 10 and 40. The study is seeking 50 participants in total."

Answered by AI

Are there still slots available for participants in this experiment?

"The data provided on clinicaltrials.gov indicates that this medical trial is not presently accepting participants, despite being first posted in January 2018 and last updated September 2021. While no longer recruiting patients, a total of 416 other studies are currently enrolling individuals."

Answered by AI

Is the minimum age for eligibility in this medical experiment limited to those above 18?

"For this research study, applicants must be between 10 and 40 years old. There are 89 trials available to those younger than 18 while 375 exist for the elderly population."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient

Maria Bano 2018. "Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03263312.