Clinical trial NCT02825472: Exercise Training in Grown-up Congenital Heart Disease
Official title: Exercise Training in Grown-up Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Heart Disease
Keywords: Congenital Heart Disease
Sport
Exercise training
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary efficacy endpoint: change in peak VO2
timeFrame: 6 months
measure: Primary safety endpoint: composite of hospitalizations, deaths during, or within three hours after exercise
timeFrame: between 3 hours after exercise for the duration of the 6 months study period
Secondary outcomes:
measure: Secondary efficacy endpoint: quality of life
timeFrame: 6 months
measure: Secondary efficacy endpoint: NTproBNP level
timeFrame: 6 months
measure: Secondary safety endpoint: composite of all exercise related injuries for which medical attention is sought
timeFrame: 6 months study period
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Department of Cardiology, I.R.C.C.S. Policlinico San Donato Milanese
state: Piazza Edmondo Malan
city: Amsterdam
country: Netherlands
facility: Hospital
state: North-Holland
Study officials:
affiliation: AIDS Malignancy Consortium
name: Barbara Mulder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: