Heart Defects, CongenitalCARE-GUCHNCT01463800
Rehabilitation in Patients With Congenital Heart Disease
A study testing Structured exercise training in people with Heart Defects, Congenital, run by University Hospital, Basel, Switzerland at 4 sites in 2 countries.
Trial summary
Exercise intolerance is a major burden for patients with complex congenital heart disease (CHD), significantly affecting their quality of life. Cardiopulmonary exercise testing provides a reliable tool both for assessing exercise capacity of CHD patients and for risk stratification and is becoming part of the routine… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- Structured exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesin 2 countries
- Study dates
- May 2011to 1 Jan 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
- Patients with complex CHD including cyanotic heart disease, subaortic right ventricle physiology, single ventricle physiology, Ebstein anomaly with ≥ moderate tricuspid regurgitation and patients with Tetralogy of Fallot (including those with pulmonary atresia of Fallot type or double-outlet right ventricle of Fallot type) and either residual free pulmonary regurgitation or left- or right ventricular systolic dysfunction (demonstrated by echocardiography or cardiac MRI).
- Peak VO2 < 85% of predicted (standardized for age, gender, weight and height) obtained by cardiopulmonary exercise testing
- Sedentary lifestyle (< 30 minutes of regular exercise per week)
Who cannot join
- Patients with dyspnea New York Heart Association (NYHA) class IV.
- Severe left ventricular outflow tract obstruction.
- Unstable angina or recent myocardial infarction (<12 months).
- Uncontrolled ventricular arrhythmia.
- Recent intervention (<12 months)
- Life expectancy <12 months
- No consent.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Switzerland3 sites
University Hospital Basel
Basel, 4052
Inselspital Bern
Bern, 3010
University Hospital Zurich
Zurich, 8091
About this study
Official title: Cardiac Rehabilitation in Patients With Complex Congenital Heart Disease: Improvement of Exercise Intolerance
Exercise intolerance is a major burden for patients with complex congenital heart disease (CHD), significantly affecting their quality of life. Cardiopulmonary exercise testing provides a reliable tool both for assessing exercise capacity of CHD patients and for risk stratification and is becoming part of the routine clinical assessment of these patients. Exercise has an effect on the muscular, metabolic and circulatory systems. While exercise training has been widely studied in chronic heart failure, its efficacy in adults with CHD remain unknown. The investigators hypothesize that structured exercise training will improve exercise intolerance, in particular peak VO2. The aim of this multicenter, randomized study is to evaluate the impact of structured exercise training on exercise intolerance in patients with complex CHD.
Read the detailed description
This is a randomized, prospective, multicenter, interventional study.
After study patients have given written consent they will be randomized either in the interventional group with a rehabilitation program or in the control group without rehabilitation program. Patients who are randomized in the control group are allowed to perform the rehabilitation program 12 months after randomisation. Patients in the interventional group will perform structured exercise training on 3 weekdays during a 12-weeks period. Training will be performed by ergometer and low-impact gymnastic and relaxation training.
All study participants have the following investigations at the beginning of the study and after 12 weeks:
- Cardiopulmonary exercise testing with spirometry
- 6-minute walk test
- Blood work: BNP, Creatinine, Sodium, Potassium, Urat, Cholesterol (HDL-L and LDL-L)
- Validated Heart failure questionnaires (SF-36 and Minnesota Living with heart failure questionnaire, German version for Basel, Zürich and Bern) All tests will be repeated as clinically indicated in a follow-up visit 12 months after baseline
Primary outcome is:
Comparison of peak VO2 at the end of rehabilitation between both groups.
Secondary outcomes are:
- Comparison of 6-min walk test, VE/VCO2 slope, anaerobic threshold and heart rate and blood pressure response after rehabilitation between both groups
- Changes of 6-min walk test, peak VO2, VE/VCO2 slope, anaerobic threshold and heart rate and blood pressure response at the end and 12 months after rehabilitation.
- Changes of quality-of-life assessed by validated heart failure questionnaire at the end and 12 months after rehabilitation and comparison between both groups.
- Changes of levels of brain-natriuretic peptide at the end and 12 months after rehabilitation.
- Adverse events during rehabilitation including new onset of arrhythmia, admission due to worsening heart failure or death.
The calculated sample size to reach a power of 0.80 is 83 patients in each arm. Patients with complex CHD and exercise intolerance are at increased risk for premature death and severe cardiac complications including arrhythmia needing treatment, heart failure and circulatory failure, pulmonary hemorrhage, pulmonary embolism and endocarditis. Hence, the likelihood of major adverse cardiac events during the study phase is considerably high. However, there is no evidence of functional worsening by low-level exercise. Smaller studies with patients with congenital heart disease and/or pulmonary hypertension did not report safety issues. Although sudden cardiac death is one of the leading modes of death in this population, it is extremely rare that sudden death occurs during exercise. Cardiac patients who are at specific risk for exercise-induced arrhythmia are not included into the study (i.e. patients with hypertrophic obstructive cardiomyopathy).
- Conditions
- Heart Defects, Congenital
- Being tested
- Structured exercise training
- Keywords
- Heart Defects, congenital
- 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.
Structured exercise trainingBehavioural
12 weeks low level ambulatory structured exercise training
| Study group | Role | What they receive |
|---|---|---|
| Structured Exercise training | Active comparator | 12 weeks ambulatory low level exercise training Receives: Behavioral: Structured exercise training |
| Control group | No intervention | No structured exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak VO2
Comparison between both groups
Measured: 12 weeks
Secondary outcomes (13)
6 minute walk test
between both groups and within groups
Measured: 12 weeks
VE/VCO2
Comparison between groups and within groups
Measured: 12 weeks
heart rate response
Difference between peak heart rate and resting heart rate Comparison between groups and within groups
Measured: 12 weeks
QoL
Comparison between groups and within groups Minnesota Heart failure Score and SF 36
Measured: 12 weeks
BNP
Comparison between groups and within groups
Measured: 12 weeks
Adverse events
cardiac related adverse events including cardiac death
Measured: 12 weeks
peak VO2
Comparison between groups and within groups
Measured: 12 months
VE/VCO2
Comparison between groups and within groups
Measured: 12 months
Heart rate response
Comparison between groups and within groups
Measured: 12 months
6 minute walk test
Comparison between groups and within groups
Measured: 12 months
QoL
Comparison between groups and within groups
Measured: 12 months
BNP
Comparison between groups and within groups
Measured: 12 months
Cardiac adverse events
Comparison between groups and within groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2016
- Study completion1 Jan 2017
Why it stopped: low inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Tobler, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463800
- Sponsor's protocol ID
- CARE-GUCH
- Acronym
- CARE-GUCH
- Status last verified
- Sep 2017
- First submitted
- 28 Oct 2011
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rehabilitation in Patients With Complex Congenital Heart Disease: Improvement of Exercise Intolerance
- ClinicalTrials.gov ID
- NCT01463800
- Acronym / sponsor ID
- CARE-GUCH / CARE-GUCH
- Conditions
- Heart Defects, Congenital
- Keywords
- Heart Defects, congenital
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low inclusion rate
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 2 Nov 2011 (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.
Exercise intolerance is a major burden for patients with complex congenital heart disease (CHD), significantly affecting their quality of life. Cardiopulmonary exercise testing provides a reliable tool both for assessing exercise capacity of CHD patients and for risk stratification and is becoming part of the routine clinical assessment of these patients. Exercise has an effect on the muscular, metabolic and circulatory systems. While exercise training has been widely studied in chronic heart failure, its efficacy in adults with CHD remain unknown. The investigators hypothesize that structured exercise training will improve exercise intolerance, in particular peak VO2. The aim of this multicenter, randomized study is to evaluate the impact of structured exercise training on exercise intolerance in patients with complex CHD.
Detailed description
This is a randomized, prospective, multicenter, interventional study.
After study patients have given written consent they will be randomized either in the interventional group with a rehabilitation program or in the control group without rehabilitation program. Patients who are randomized in the control group are allowed to perform the rehabilitation program 12 months after randomisation. Patients in the interventional group will perform structured exercise training on 3 weekdays during a 12-weeks period. Training will be performed by ergometer and low-impact gymnastic and relaxation training.
All study participants have the following investigations at the beginning of the study and after 12 weeks:
- Cardiopulmonary exercise testing with spirometry
- 6-minute walk test
- Blood work: BNP, Creatinine, Sodium, Potassium, Urat, Cholesterol (HDL-L and LDL-L)
- Validated Heart failure questionnaires (SF-36 and Minnesota Living with heart failure questionnaire, German version for Basel, Zürich and Bern) All tests will be repeated as clinically indicated in a follow-up visit 12 months after baseline
Primary outcome is:
Comparison of peak VO2 at the end of rehabilitation between both groups.
Secondary outcomes are:
- Comparison of 6-min walk test, VE/VCO2 slope, anaerobic threshold and heart rate and blood pressure response after rehabilitation between both groups
- Changes of 6-min walk test, peak VO2, VE/VCO2 slope, anaerobic threshold and heart rate and blood pressure response at the end and 12 months after rehabilitation.
- Changes of quality-of-life assessed by validated heart failure questionnaire at the end and 12 months after rehabilitation and comparison between both groups.
- Changes of levels of brain-natriuretic peptide at the end and 12 months after rehabilitation.
- Adverse events during rehabilitation including new onset of arrhythmia, admission due to worsening heart failure or death.
The calculated sample size to reach a power of 0.80 is 83 patients in each arm. Patients with complex CHD and exercise intolerance are at increased risk for premature death and severe cardiac complications including arrhythmia needing treatment, heart failure and circulatory failure, pulmonary hemorrhage, pulmonary embolism and endocarditis. Hence, the likelihood of major adverse cardiac events during the study phase is considerably high. However, there is no evidence of functional worsening by low-level exercise. Smaller studies with patients with congenital heart disease and/or pulmonary hypertension did not report safety issues. Although sudden cardiac death is one of the leading modes of death in this population, it is extremely rare that sudden death occurs during exercise. Cardiac patients who are at specific risk for exercise-induced arrhythmia are not included into the study (i.e. patients with hypertrophic obstructive cardiomyopathy).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Exercise training | Active comparator | Behavioral: Structured exercise training12 weeks ambulatory low level exercise training |
| Control group | No intervention | –No structured exercise training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with complex CHD including cyanotic heart disease, subaortic right ventricle physiology, single ventricle physiology, Ebstein anomaly with ≥ moderate tricuspid regurgitation and patients with Tetralogy of Fallot (including those with pulmonary atresia of Fallot type or double-outlet right ventricle of Fallot type) and either residual free pulmonary regurgitation or left- or right ventricular systolic dysfunction (demonstrated by echocardiography or cardiac MRI).
- Peak VO2 < 85% of predicted (standardized for age, gender, weight and height) obtained by cardiopulmonary exercise testing
- Sedentary lifestyle (< 30 minutes of regular exercise per week)
Key exclusion criteria (7 listed)
- Patients with dyspnea New York Heart Association (NYHA) class IV.
- Severe left ventricular outflow tract obstruction.
- Unstable angina or recent myocardial infarction (<12 months).
- Uncontrolled ventricular arrhythmia.
- Recent intervention (<12 months)
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 |
|---|---|---|
| Structured exercise training12 weeks low level ambulatory structured exercise training | Behavioural | Structured Exercise training |
Primary outcome
peak VO2
Time frame: 12 weeks
Comparison between both groups
13 secondary outcomes
6 minute walk test
Time frame: 12 weeks
VE/VCO2
Time frame: 12 weeks
heart rate response
Time frame: 12 weeks
QoL
Time frame: 12 weeks
BNP
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
peak VO2
Time frame: 12 months
VE/VCO2
Time frame: 12 months
Heart rate response
Time frame: 12 months
6 minute walk test
Time frame: 12 months
QoL
Time frame: 12 months
BNP
Time frame: 12 months
Cardiac adverse events
Time frame: 12 months
Results and safety
The study was stopped early (reason given: low inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
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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.
Daniel Tobler, MD principal investigator
University Hospital, Basel, Switzerland
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured exercise training in people with Heart Defects, Congenital, run by University Hospital, Basel, Switzerland at 4 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: stopped early, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland, Spain. 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?
The study was stopped early (reason given: low inclusion rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak VO2 (time frame: 12 weeks). 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 2 Oct 2017.