Status:
COMPLETED
Exercise Training in Patients With Left Ventricular Assist Device
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
University of Göttingen
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 contin...
Eligibility Criteria
Inclusion
- chronic end-stage systolic heart failure
- stable on left ventricular assist device, meaning
- 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
- post implantation ≥ 3 months
- 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
- 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
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03369938
Start Date
December 4 2017
End Date
December 31 2020
Last Update
January 27 2021
Active Locations (5)
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1
Charité - Universitätsmedizin Berlin und Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
2
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
3
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
4
Herzzentrum Leipzig
Leipzig, Germany, 04289