- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01463800
Rehabilitation in Patients With Congenital Heart Disease (CARE-GUCH)
Cardiac Rehabilitation in Patients With Complex Congenital Heart Disease: Improvement of Exercise Intolerance
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Sevilla, Spain
- Virgen Macarena University Hospital
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-
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Basel, Switzerland, 4052
- University Hospital Basel
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Bern, Switzerland, 3010
- Inselspital Bern
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Zurich, Switzerland, 8091
- University Hospital Zurich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Structured Exercise training
12 weeks ambulatory low level exercise training
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12 weeks low level ambulatory structured exercise training
|
No Intervention: Control group
No structured exercise training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
peak VO2
Time Frame: 12 weeks
|
Comparison between both groups
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 minute walk test
Time Frame: 12 weeks
|
between both groups and within groups
|
12 weeks
|
VE/VCO2
Time Frame: 12 weeks
|
Comparison between groups and within groups
|
12 weeks
|
heart rate response
Time Frame: 12 weeks
|
Difference between peak heart rate and resting heart rate Comparison between groups and within groups
|
12 weeks
|
QoL
Time Frame: 12 weeks
|
Comparison between groups and within groups Minnesota Heart failure Score and SF 36
|
12 weeks
|
BNP
Time Frame: 12 weeks
|
Comparison between groups and within groups
|
12 weeks
|
Adverse events
Time Frame: 12 weeks
|
cardiac related adverse events including cardiac death
|
12 weeks
|
peak VO2
Time Frame: 12 months
|
Comparison between groups and within groups
|
12 months
|
VE/VCO2
Time Frame: 12 months
|
Comparison between groups and within groups
|
12 months
|
Heart rate response
Time Frame: 12 months
|
Comparison between groups and within groups
|
12 months
|
6 minute walk test
Time Frame: 12 months
|
Comparison between groups and within groups
|
12 months
|
QoL
Time Frame: 12 months
|
Comparison between groups and within groups
|
12 months
|
BNP
Time Frame: 12 months
|
Comparison between groups and within groups
|
12 months
|
Cardiac adverse events
Time Frame: 12 months
|
Comparison between groups and within groups
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CARE-GUCH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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