Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2016-02-29
2017-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exercise training program
Six-months sports participation, three times per week for 30 minutes in the target heart rate zone
exercise training
3 times per week 30 minutes of exercise training in the target heart rate zone
No exercise training program
no exercise training program, usual care
No interventions assigned to this group
Interventions
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exercise training
3 times per week 30 minutes of exercise training in the target heart rate zone
Eligibility Criteria
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Inclusion Criteria
* Congenital heart disease of all complexities
* NYHA Class II or III
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Berto J Bouma
MD, PhD
Principal Investigators
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Barbara Mulder, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
AIDS Malignancy Consortium
Locations
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Department of Cardiology, I.R.C.C.S. Policlinico San Donato Milanese
Milan, Piazza Edmondo Malan, Italy
Hospital
Amsterdam, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL5378201815
Identifier Type: -
Identifier Source: org_study_id
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