NCT02825472

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

July 7, 2016

Status Verified

July 1, 2016

Enrollment Period

1.6 years

First QC Date

June 23, 2016

Last Update Submit

July 6, 2016

Conditions

Congenital Heart Disease

Keywords

Congenital Heart DiseaseSportExercise training

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Secondary efficacy endpoint: quality of life

    6 months

  • Secondary efficacy endpoint: NTproBNP level

    6 months

  • Secondary safety endpoint: composite of all exercise related injuries for which medical attention is sought

    6 months study period

Study Arms (2)

Exercise training program

ACTIVE COMPARATOR

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

Behavioral: exercise training

No exercise training program

NO INTERVENTION

no exercise training program, usual care

Interventions

exercise trainingBEHAVIORAL

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

Exercise training program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Congenital heart disease of all complexities
  • NYHA Class II or III

You may not qualify if:

  • Inability to give informed consent
  • Inability to participate in an exercise training program
  • Exercise-induced arrhythmia and/or ischemia
  • Cyanosis at rest
  • Pregnancy
  • Participation in interventional clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Milan, Piazza Edmondo Malan, 20097, Italy

NOT YET RECRUITING

Hospital

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Barbara Mulder, MD, PhD

    AIDS Malignancy Consortium

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Berto Bouma, MD, PhD

CONTACT

0031205669111b.j.bouma@amc.uva.nl

Michiel Winter, MD, PhD

CONTACT

0031205669111m.m.winter@amc.uva.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 23, 2016

First Posted

July 7, 2016

Study Start

February 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

July 7, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)IT(1)