Clinical trial NCT03369938: Exercise Training in Patients With Left Ventricular Assist Device
Official title: Exercise Training in Patients With Left Ventricular Assist Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: left ventricular assist device
exercise training
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
name: University of Göttingen
name: University Medicine Greifswald
name: Technical University of Munich
name: University of Leipzig
First posted: 2017-12-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: change in maximal exercise capacity
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: change in ventilatory efficacy
timeFrame: after 12 weeks of treatment and 12 weeks of follow-up
measure: change in submaximal exercise tolerance
timeFrame: after 12 weeks of treatment and 12 weeks of follow-up
measure: change in muscle strength
timeFrame: after 12 weeks of treatment and 12 weeks of follow-up
measure: change in body composition
timeFrame: after 12 weeks of treatment and 12 weeks of follow-up
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: after 12 weeks of treatment and 12 weeks of follow-up
measure: 36-Item Short Form Survey (SF-36)
timeFrame: after 12 weeks of treatment and 12 weeks of follow-up
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: after 12 weeks of treatment and 12 weeks of follow-up
measure: change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
timeFrame: after 12 weeks of treatment and 12 weeks of follow-up
measure: change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
timeFrame: after 12 weeks of treatment and 12 weeks of follow-up
measure: change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
timeFrame: after 12 weeks of treatment and 12 weeks of follow-up
measure: change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
timeFrame: after 12 weeks of treatment and 12 weeks of follow-up
measure: change in markers of neuroendocrine activation
timeFrame: after 12 weeks of treatment and 12 weeks of follow-up
measure: change in daily physical activity
timeFrame: up to 12 weeks of treatment and 12 weeks of follow-up
measure: change in daily physical activity
timeFrame: up to 12 weeks of treatment and 12 weeks of follow-up
Other outcomes:
measure: adherence to exercise training
timeFrame: up to 12 weeks of treatment
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin und Deutsches Herzzentrum Berlin
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München und Klinikum der Universität München
Study officials:
References: