Heart Failure
Conditions
Keywords
left ventricular assist device, exercise training
Brief summary
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).
Interventions
structured aerobic endurance/resistance training on top of usual care for 12 weeks (3x/week)
Sponsors
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
University of Göttingen
University Medicine Greifswald
Technical University of Munich
University of Leipzig
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* chronic end-stage systolic heart failure * stable on left ventricular assist device, meaning 1. no major change in therapeutic regime within past 4 weeks: no new additional disease modifying drug (ACE inhibitor, ARB, sacubitril, beta-blocker), no change in disease modifying drug dosage more than 50% (excluded: diuretics), no initiation of a cardiac rehabilitation for a minimum of 4 weeks 2. post implantation ≥ 3 months 3. expected further period on the device for a minimum of 3 months after recruitment into the study * 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
* acute illness that does not allow exercise, including unstable heart failure, acute myocarditis, acute pericarditis, stroke * untreated life-threatening cardiac arrhythmias * uncontrolled hypertension * intracardiac thrombus * inability to perform cardiopulmonary exercise testing at least 1 minute at 20W * uncontrolled diabetes * uncontrolled kidney disease * recent embolism * concurrent, continuous, or intermittent dobutamine therapy * complex ventricular arrhythmia at rest or appearing with exertion * supine resting heart rate \> 100 beats per minute * severe pulmonary instability * hemodynamically relevant valvular disorders * significant change in cardiovascular medication within the previous 4 weeks (see inclusion criteria) * severe anemia (hemoglobin \<8 g/dl), however patients with moderate anemia (hemoglobin \<11 g/dl) may be recruited if clinically stable (investigator assessment) * clinically relevant musculoskeletal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in maximal exercise capacity | after 12 weeks of treatment | cardiopulmonary exercise testing (CPET; peakVO2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in ventilatory efficacy | after 12 weeks of treatment and 12 weeks of follow-up | cardiopulmonary exercise testing (CPET; VE/VCO2 slope) |
| change in submaximal exercise tolerance | after 12 weeks of treatment and 12 weeks of follow-up | 6-minute-walk distance (m), anaerobic threshold (VO2 at AT) |
| change in muscle strength | after 12 weeks of treatment and 12 weeks of follow-up | handgrip (kg) |
| change in body composition | after 12 weeks of treatment and 12 weeks of follow-up | % fat mass |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | after 12 weeks of treatment and 12 weeks of follow-up | patient-reported measure of quality of life for patients with heart failure |
| Patient Health Questionnaire (PHQ-9) | after 12 weeks of treatment and 12 weeks of follow-up | patient-reported measure of presence and severity of depression |
| change in echocardiographic parameters of cardiac morphology and function at rest and during exercise | after 12 weeks of treatment and 12 weeks of follow-up | left ventricular ejection fraction (%) |
| change in markers of neuroendocrine activation | after 12 weeks of treatment and 12 weeks of follow-up | NT-proBNP (ng/l) |
| change in daily physical activity | up to 12 weeks of treatment and 12 weeks of follow-up | physical activity diary |
| 36-Item Short Form Survey (SF-36) | after 12 weeks of treatment and 12 weeks of follow-up | patient-reported measure of health status |
Other
| Measure | Time frame | Description |
|---|---|---|
| adherence to exercise training | up to 12 weeks of treatment | accelerometry |
Countries
Germany
Outcome results
None listed