Rehabilitation in Patients With Congenital Heart Disease (CARE-GUCH)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||Cardiac Rehabilitation in Patients With Complex Congenital Heart Disease: Improvement of Exercise Intolerance|
- peak VO2 [ Time Frame: 12 weeks ]Comparison between both groups
- 6 minute walk test [ Time Frame: 12 weeks ]between both groups and within groups
- VE/VCO2 [ Time Frame: 12 weeks ]Comparison between groups and within groups
- heart rate response [ Time Frame: 12 weeks ]Difference between peak heart rate and resting heart rate Comparison between groups and within groups
- QoL [ Time Frame: 12 weeks ]Comparison between groups and within groups Minnesota Heart failure Score and SF 36
- BNP [ Time Frame: 12 weeks ]Comparison between groups and within groups
- Adverse events [ Time Frame: 12 weeks ]cardiac related adverse events including cardiac death
- peak VO2 [ Time Frame: 12 months ]Comparison between groups and within groups
- VE/VCO2 [ Time Frame: 12 months ]Comparison between groups and within groups
- Heart rate response [ Time Frame: 12 months ]Comparison between groups and within groups
- 6 minute walk test [ Time Frame: 12 months ]Comparison between groups and within groups
- QoL [ Time Frame: 12 months ]Comparison between groups and within groups
- BNP [ Time Frame: 12 months ]Comparison between groups and within groups
- Cardiac adverse events [ Time Frame: 12 months ]Comparison between groups and within groups
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Structured Exercise training
12 weeks ambulatory low level exercise training
Behavioral: Structured exercise training
12 weeks low level ambulatory structured exercise training
No Intervention: Control group
No structured exercise training
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463800
|Contact: Daniel Tobler, MDfirstname.lastname@example.org|
|Virgen Macarena University Hospital||Recruiting|
|Contact: Pastora Gallego, MD email@example.com|
|Principal Investigator: Pastora Gallego, MD|
|University Hospital Basel||Recruiting|
|Basel, Switzerland, 4052|
|Contact: Daniel Tobler, MD firstname.lastname@example.org|
|Principal Investigator: Daniel Tobler, MD|
|Sub-Investigator: Hoffmann Andreas, MD|
|Bern, Switzerland, 3010|
|Contact: Markus Schwerzmann, MD +41316327859|
|Principal Investigator: Markus Schwerzmann, MD|
|Sub-Investigator: Kerstin Khattab, MD|
|University Hospital Zurich||Recruiting|
|Zurich, Switzerland, 8091|
|Contact: Matthias Greutmann, MD email@example.com|
|Principal Investigator: Matthias Greutmann, MD|
|Principal Investigator:||Daniel Tobler, MD||University Hospital, Basel, Switzerland|