Exercise Training in Patients With Left Ventricular Assist Device

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: exercise training intervention

• Registration Number: NCT03369938
• Lead Sponsor: Charite University, Berlin, Germany

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-15
• Study Start: 2017-12-04
• Study First Submitted QC: 2017-12-11
• Study First Posted: 2017-12-12
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise training intervention	exercise training intervention	-

Primary Outcome Measures

Name	Time	Method
change in maximal exercise capacity	after 12 weeks of treatment	cardiopulmonary exercise testing (CPET; peakVO2)

Secondary Outcome Measures

Name	Time	Method
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
36-Item Short Form Survey (SF-36)	after 12 weeks of treatment and 12 weeks of follow-up	patient-reported measure of health status
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	tricuspid annular plane systolic excursion (TAPSE; mm)
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	accelerometry
change in ventilatory efficacy	after 12 weeks of treatment and 12 weeks of follow-up	cardiopulmonary exercise testing (CPET; VE/VCO2 slope)

Trial Locations

Locations (5)

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Klinikum rechts der Isar der Technischen Universität München und Klinikum der Universität München; 🇩🇪 München, Germany

Charité - Universitätsmedizin Berlin und Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany