Congenital Heart Disease Clinical Trial
Official title:
Exercise Training in Grown-up Congenital Heart Disease
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.
The investigators intend to submit the trial design of this study for this purpose. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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