Congenital Heart DiseaseExTra-GUCHNCT02825472
Exercise Training in Grown-up Congenital Heart Disease
A study testing exercise training in people with Congenital Heart Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Congenital heart disease of all complexities
- NYHA Class II or III
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Not yet recruiting
Department of Cardiology, I.R.C.C.S. Policlinico San Donato Milanese
Milan, Piazza Edmondo Malan, 20097
Massimo Chessa, MD, PhD, 0039252774531, massimo.chessa@grupposandonato.it
Massimo Chessa, MD, PhD
Netherlands1 site, 1 recruiting
- Recruiting
Hospital
Amsterdam, North Holland, 1105AZ
Berto Bouma, MD, PhD, 0031205669111, b.j.bouma@amc.uva.nl
Michiel Winter, MD, PhD, 0031205669111, m.m.winter@amc.uva.nl
About this study
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.
Read more
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.
Read the detailed description
The investigators intend to submit the trial design of this study for this purpose.
- Conditions
- Congenital Heart Disease
- Being tested
- exercise training
- Keywords
- Congenital Heart Disease, Sport, Exercise training
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingBehavioural
3 times per week 30 minutes of exercise training in the target heart rate zone
| Study group | Role | What they receive |
|---|---|---|
| Exercise training program | Active comparator | Six-months sports participation, three times per week for 30 minutes in the target heart rate zone Receives: Behavioral: exercise training |
| No exercise training program | No intervention | no exercise training program, usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint: change in peak VO2
change in peak VO2 between baseline and 6-months follow-up CPET
Measured: 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.
Measured: between 3 hours after exercise for the duration of the 6 months study period
Secondary outcomes (3)
Secondary efficacy endpoint: quality of life
change in SF36 scores between baseline and 6-months follow-up
Measured: 6 months
Secondary efficacy endpoint: NTproBNP level
change in NTproBNP between baseline and 6-months follow-up
Measured: 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
Measured: 6 months study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berto J Bouma, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Barbara Mulder, MD, PhD, Principal investigator, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825472
- Sponsor's protocol ID
- NL5378201815
- Acronym
- ExTra-GUCH
- Status last verified
- Jul 2016
- First submitted
- 23 Jun 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training in Grown-up Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT02825472
- Acronym / sponsor ID
- ExTra-GUCH / NL5378201815
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital Heart Disease, Sport, Exercise training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Feb 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training program | Active comparator | Behavioral: exercise trainingSix-months sports participation, three times per week for 30 minutes in the target heart rate zone |
| No exercise training program | No intervention | –no exercise training program, usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Congenital heart disease of all complexities
- NYHA Class II or III
Key exclusion criteria (7 listed)
- Inability to give informed consent
- Inability to participate in an exercise training program
- Exercise-induced arrhythmia and/or ischemia
- Cyanosis at rest
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise training3 times per week 30 minutes of exercise training in the target heart rate zone | Behavioural | Exercise training program |
Primary outcome
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.
3 secondary outcomes
Secondary efficacy endpoint: quality of life
Time frame: 6 months
Secondary efficacy endpoint: NTproBNP level
Time frame: 6 months
Secondary safety endpoint: composite of all exercise related injuries for which medical attention is sought
Time frame: 6 months study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Mulder, MD, PhD principal investigator
AIDS Malignancy Consortium
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with Congenital Heart Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berto Bouma, MD, PhD (0031205669111, b.j.bouma@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoint: change in peak VO2 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2016.