Exercise Training in Grown-up Congenital Heart Disease

Study Overview
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Brief Summary
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Rationale: Regular physical activity and aerobic exercise training are related to decreased cardiovascular mortality in healthy individuals, as well as in individuals with cardiovascular risk factors and cardiac patients. Unfortunately, no such data is available on exercise training in adult patients with congenital heart disease. Objective: The objective of the ExTra GUCH trial is to assess whether encouragement of a six-month sports participation program in addition to usual care in symptomatic adult patients with congenital heart disease improves exercise capacity and quality of life, and lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels. Study design: International, multi-centre parallel randomized controlled trial. Study population: Adult patients with congenital heart disease, who are in New York Heart Association (NYHA) class II or III. Intervention (if applicable): The intervention group receives a six-month individualized exercise training program, the control group receives usual care. Main study parameters/endpoints: The primary outcome is the change in peakVO2 between patients in the sports participation group, and the control group. Secondary outcome measures are change in NYHA functional class, quality of life, and NT-proBNP levels. The primary safety outcome is the composite of all hospitalizations, and all deaths during, or within three hours after exercise. The secondary safety outcome is the composite of all exercise related injuries for which medical attention is sought.

Detailed Description
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The investigators intend to submit the trial design of this study for this purpose.

Official Title
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Exercise Training in Grown-up Congenital Heart Disease

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Behavioral: exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Congenital heart disease of all complexities NYHA Class II or III Exclusion Criteria: Inability to give informed consent Inability to participate in an exercise training program Exercise-induced arrhythmia and/or ischemia Cyanosis at rest Pregnancy Major cardiovascular event and/or procedure within three months previous to inclusion. Participation in interventional clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise training program<br>Six-months sports participation, three times per week for 30 minutes in the target heart rate zone | Behavioral: exercise training<br>* 3 times per week 30 minutes of exercise training in the target heart rate zone<br>|
| No Intervention: No exercise training program<br>no exercise training program, usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy endpoint: change in peak VO2 | change in peak VO2 between baseline and 6-months follow-up CPET | 6 months | 
| Primary safety endpoint: composite of hospitalizations, deaths during, or within three hours after exercise | The primary safety outcome is the composite of all hospitalizations, and all deaths during, or within three hours after exercise. | between 3 hours after exercise for the duration of the 6 months study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy endpoint: quality of life | change in SF36 scores between baseline and 6-months follow-up | 6 months | 
| Secondary efficacy endpoint: NTproBNP level | change in NTproBNP between baseline and 6-months follow-up | 6 months | 
| Secondary safety endpoint: composite of all exercise related injuries for which medical attention is sought | The secondary safety outcome is the composite of all exercise related injuries for which medical attention is sought during the study period | 6 months study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital Heart Disease, Sport, Exercise training