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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
3 times per week 30 minutes of exercise training in the target heart rate zone
Department of Cardiology, I.R.C.C.S. Policlinico San Donato Milanese
Milan, Piazza Edmondo Malan, Italy
NOT_YET_RECRUITINGHospital
Amsterdam, North Holland, Netherlands
RECRUITINGPrimary efficacy endpoint: change in peak VO2
change in peak VO2 between baseline and 6-months follow-up CPET
Time frame: 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.
Time frame: between 3 hours after exercise for the duration of the 6 months study period
Secondary efficacy endpoint: quality of life
change in SF36 scores between baseline and 6-months follow-up
Time frame: 6 months
Secondary efficacy endpoint: NTproBNP level
change in NTproBNP between baseline and 6-months follow-up
Time frame: 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
Time frame: 6 months study period
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