Congenital Heart Disease
Conditions
Keywords
Congenital Heart Disease, Sport, Exercise training
Brief summary
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
The investigators intend to submit the trial design of this study for this purpose.
Interventions
BEHAVIORALexercise training
3 times per week 30 minutes of exercise training in the target heart rate zone
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary efficacy endpoint: change in peak VO2 | 6 months | change in peak VO2 between baseline and 6-months follow-up CPET |
| Primary safety endpoint: composite of hospitalizations, deaths during, or within three hours after exercise | between 3 hours after exercise for the duration of the 6 months study period | The primary safety outcome is the composite of all hospitalizations, and all deaths during, or within three hours after exercise. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary efficacy endpoint: quality of life | 6 months | change in SF36 scores between baseline and 6-months follow-up |
| Secondary efficacy endpoint: NTproBNP level | 6 months | change in NTproBNP between baseline and 6-months follow-up |
| Secondary safety endpoint: composite of all exercise related injuries for which medical attention is sought | 6 months study period | The secondary safety outcome is the composite of all exercise related injuries for which medical attention is sought during the study period |
Countries
Italy, Netherlands
Contacts
Primary ContactBerto Bouma, MD, PhD
Backup ContactMichiel Winter, MD, PhD
Outcome results
None listed