Exercise Training in Grown-up Congenital Heart Disease

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2017

Detailed Description

The investigators intend to submit the trial design of this study for this purpose.

Interventions

  • Behavioral: exercise training
    • 3 times per week 30 minutes of exercise training in the target heart rate zone

Arms, Groups and Cohorts

  • Active Comparator: Exercise training program
    • Six-months sports participation, three times per week for 30 minutes in the target heart rate zone
  • No Intervention: No exercise training program
    • no exercise training program, usual care

Clinical Trial Outcome Measures

Primary Measures

  • Primary efficacy endpoint: change in peak VO2
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Secondary efficacy endpoint: quality of life
    • Time Frame: 6 months
    • change in SF36 scores between baseline and 6-months follow-up
  • Secondary efficacy endpoint: NTproBNP level
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Berto J Bouma, MD, PhD – Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA)
  • Overall Official(s)
    • Barbara Mulder, MD, PhD, Principal Investigator, AIDS Malignancy Consortium
  • Overall Contact(s)
    • Berto Bouma, MD, PhD, 0031205669111, b.j.bouma@amc.uva.nl

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.