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

Primary Purpose

Congenital Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
exercise training
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease focused on measuring Congenital Heart Disease, Sport, Exercise training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiology, I.R.C.C.S. Policlinico San Donato Milanese
  • HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Exercise training program

No exercise training program

Arm Description

Six-months sports participation, three times per week for 30 minutes in the target heart rate zone

no exercise training program, usual care

Outcomes

Primary Outcome Measures

Primary efficacy endpoint: change in peak VO2
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
The primary safety outcome is the composite of all hospitalizations, and all deaths during, or within three hours after exercise.

Secondary Outcome Measures

Secondary efficacy endpoint: quality of life
change in SF36 scores between baseline and 6-months follow-up
Secondary efficacy endpoint: NTproBNP level
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
The secondary safety outcome is the composite of all exercise related injuries for which medical attention is sought during the study period

Full Information

First Posted
June 23, 2016
Last Updated
July 6, 2016
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT02825472
Brief Title
Exercise Training in Grown-up Congenital Heart Disease
Acronym
ExTra-GUCH
Official Title
Exercise Training in Grown-up Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Congenital Heart Disease, Sport, Exercise training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise training program
Arm Type
Active Comparator
Arm Description
Six-months sports participation, three times per week for 30 minutes in the target heart rate zone
Arm Title
No exercise training program
Arm Type
No Intervention
Arm Description
no exercise training program, usual care
Intervention Type
Behavioral
Intervention Name(s)
exercise training
Intervention Description
3 times per week 30 minutes of exercise training in the target heart rate zone
Primary Outcome Measure Information:
Title
Primary efficacy endpoint: change in peak VO2
Description
change in peak VO2 between baseline and 6-months follow-up CPET
Time Frame
6 months
Title
Primary safety endpoint: composite of hospitalizations, deaths during, or within three hours after exercise
Description
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 Outcome Measure Information:
Title
Secondary efficacy endpoint: quality of life
Description
change in SF36 scores between baseline and 6-months follow-up
Time Frame
6 months
Title
Secondary efficacy endpoint: NTproBNP level
Description
change in NTproBNP between baseline and 6-months follow-up
Time Frame
6 months
Title
Secondary safety endpoint: composite of all exercise related injuries for which medical attention is sought
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Berto Bouma, MD, PhD
Phone
0031205669111
Email
b.j.bouma@amc.uva.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Michiel Winter, MD, PhD
Phone
0031205669111
Email
m.m.winter@amc.uva.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Mulder, MD, PhD
Organizational Affiliation
AIDS Malignancy Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, I.R.C.C.S. Policlinico San Donato Milanese
City
Milan
State/Province
Piazza Edmondo Malan
ZIP/Postal Code
20097
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Chessa, MD, PhD
Phone
0039252774531
Email
massimo.chessa@grupposandonato.it
First Name & Middle Initial & Last Name & Degree
Massimo Chessa, MD, PhD
First Name & Middle Initial & Last Name & Degree
Roberto Tramarin, MD, PhD
First Name & Middle Initial & Last Name & Degree
Francesca Pluchinotta, MD, PhD
Facility Name
Hospital
City
Amsterdam
State/Province
North-Holland
ZIP/Postal Code
1105AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berto Bouma, MD, PhD
Phone
0031205669111
Email
b.j.bouma@amc.uva.nl
First Name & Middle Initial & Last Name & Degree
Michiel Winter, MD, PhD
Phone
0031205669111
Email
m.m.winter@amc.uva.nl
First Name & Middle Initial & Last Name & Degree
Barbara Mulder, MD, PhD
First Name & Middle Initial & Last Name & Degree
Michiel Winter, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ilja Blok, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise Training in Grown-up Congenital Heart Disease

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