Exercise Training in Grown-up Congenital Heart Disease (ExTra-GUCH)

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 Overview

• Status: Unknown
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Behavioral: exercise training

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Piazza Edmondo Malan
    • Milan, Piazza Edmondo Malan, Italy, 20097
      • Not yet recruiting
      • Department of Cardiology, I.R.C.C.S. Policlinico San Donato Milanese
      • Contact: Massimo Chessa, MD, PhD; Phone Number: 0039252774531; Email: massimo.chessa@grupposandonato.it
      • Principal Investigator: Massimo Chessa, MD, PhD
      • Sub-Investigator: Roberto Tramarin, MD, PhD
      • Sub-Investigator: Francesca Pluchinotta, MD, PhD
• Netherlands
  • North-Holland
    • Amsterdam, North-Holland, Netherlands, 1105AZ
      • Recruiting
      • Hospital
      • Contact: Berto Bouma, MD, PhD; Phone Number: 0031205669111; Email: b.j.bouma@amc.uva.nl
      • Contact: Michiel Winter, MD, PhD; Phone Number: 0031205669111; Email: m.m.winter@amc.uva.nl
      • Principal Investigator: Barbara Mulder, MD, PhD
      • Sub-Investigator: Michiel Winter, MD, PhD
      • Sub-Investigator: Ilja Blok, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exercise training program; Six-months sports participation, three times per week for 30 minutes in the target heart rate zone	Behavioral: exercise training; 3 times per week 30 minutes of exercise training in the target heart rate zone
No Intervention: No exercise training program; no exercise training program, usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary efficacy endpoint: change in peak VO2	change in peak VO2 between baseline and 6-months follow-up CPET	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.	between 3 hours after exercise for the duration of the 6 months study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary efficacy endpoint: quality of life	change in SF36 scores between baseline and 6-months follow-up	6 months
Secondary efficacy endpoint: NTproBNP level	change in NTproBNP between baseline and 6-months follow-up	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	6 months study period

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Barbara Mulder, MD, PhD, AIDS Malignancy Consortium

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Estimate): July 7, 2016
• Last Update Submitted That Met QC Criteria: July 6, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; Exercise training; Sport
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: NL5378201815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO