Exercise Training in Grown-up Congenital Heart Disease

Congenital Heart Disease Clinical Trial

— ExTra-GUCH  

Official title:

Exercise Training in Grown-up Congenital Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02825472
• Other study ID #: NL5378201815
• Status: Recruiting
• Phase: N/A
• First received: June 23, 2016
• Last updated: July 6, 2016
• Start date: February 2016
• Est. completion date: September 2017

Study information

• Verified date: July 2016
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Berto Bouma, MD, PhD
• Phone: 0031205669111
• Email: b.j.bouma[@]amc.uva.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
Italy	Department of Cardiology, I.R.C.C.S. Policlinico San Donato Milanese	Milan	Piazza Edmondo Malan
Netherlands	Hospital	Amsterdam	North-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Countries where clinical trial is conducted

Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy endpoint: change in peak VO2	change in peak VO2 between baseline and 6-months follow-up CPET	6 months	No
Primary	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	Yes
Secondary	Secondary efficacy endpoint: quality of life	change in SF36 scores between baseline and 6-months follow-up	6 months	No
Secondary	Secondary efficacy endpoint: NTproBNP level	change in NTproBNP between baseline and 6-months follow-up	6 months	No
Secondary	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	Yes