Exercise Training in Patients with Left Ventricular Assist Device (Ex-VAD-DZHK11)

ID

NCT03369938

Status

Closed

DZG

DZHK

Start date

12/04/2017

Parameters

Inclusion criteria
  • 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 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