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| Name | Class |
|---|---|
| Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) | OTHER |
| University of Göttingen | OTHER |
| University Medicine Greifswald | OTHER |
| Technical University of Munich |
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The objective of the study is to test whether 12 weeks of structured supervised exercise training on top of usual care improves functional capacity in patients with end-stage heart failure with continuous flow left ventricular assist device (LVAD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exercise training intervention | Experimental |
| |
| usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise training intervention | Other | structured aerobic endurance/resistance training on top of usual care for 12 weeks (3x/week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in maximal exercise capacity | cardiopulmonary exercise testing (CPET; peakVO2) | after 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| change in ventilatory efficacy | cardiopulmonary exercise testing (CPET; VE/VCO2 slope) | after 12 weeks of treatment and 12 weeks of follow-up |
| change in submaximal exercise tolerance | 6-minute-walk distance (m), anaerobic threshold (VO2 at AT) |
| Measure | Description | Time Frame |
|---|---|---|
| adherence to exercise training | accelerometry | up to 12 weeks of treatment |
Inclusion Criteria:
chronic end-stage systolic heart failure
stable on left ventricular assist device, meaning
ability to complete the study in compliance with the protocol.
general ability of the patient to declare willingness to participate in the trial.
written informed consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin und Deutsches Herzzentrum Berlin | Berlin | 13353 | Germany | |||
| Universitätsklinikum Düsseldorf |
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| Label | URL |
|---|---|
| Ex-VAD trial website | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| University of Leipzig | OTHER |
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| after 12 weeks of treatment and 12 weeks of follow-up |
| change in muscle strength | handgrip (kg) | after 12 weeks of treatment and 12 weeks of follow-up |
| change in body composition | % fat mass | after 12 weeks of treatment and 12 weeks of follow-up |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | patient-reported measure of quality of life for patients with heart failure | after 12 weeks of treatment and 12 weeks of follow-up |
| 36-Item Short Form Survey (SF-36) | patient-reported measure of health status | after 12 weeks of treatment and 12 weeks of follow-up |
| Patient Health Questionnaire (PHQ-9) | patient-reported measure of presence and severity of depression | after 12 weeks of treatment and 12 weeks of follow-up |
| change in echocardiographic parameters of cardiac morphology and function at rest and during exercise | left ventricular ejection fraction (%) | after 12 weeks of treatment and 12 weeks of follow-up |
| change in echocardiographic parameters of cardiac morphology and function at rest and during exercise | left ventricular end diastolic volume (ml) | after 12 weeks of treatment and 12 weeks of follow-up |
| change in echocardiographic parameters of cardiac morphology and function at rest and during exercise | left ventricular end diastolic diameters (mm) | after 12 weeks of treatment and 12 weeks of follow-up |
| change in echocardiographic parameters of cardiac morphology and function at rest and during exercise | tricuspid annular plane systolic excursion (TAPSE; mm) | after 12 weeks of treatment and 12 weeks of follow-up |
| change in markers of neuroendocrine activation | NT-proBNP (ng/l) | after 12 weeks of treatment and 12 weeks of follow-up |
| change in daily physical activity | physical activity diary | up to 12 weeks of treatment and 12 weeks of follow-up |
| change in daily physical activity | accelerometry | up to 12 weeks of treatment and 12 weeks of follow-up |
| Düsseldorf |
| 40225 |
| Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Herzzentrum Leipzig | Leipzig | 04289 | Germany |
| Klinikum rechts der Isar der Technischen Universität München und Klinikum der Universität München | München | 80992 | Germany |