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

Charité University Medicine Berlin

Status: Completed

Conditions: Heart Failure

Treatments: Other: exercise training intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03369938

Ex-VAD

Details and patient eligibility

About

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).

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

exercise training intervention

Experimental group

Treatment:

Other: exercise training intervention

usual care

No Intervention group