Exercise Training in Patients With Left Ventricular Assist Device

Heart Failure Clinical Trial

— Ex-VAD  

Official title:

Exercise Training in Patients With Left Ventricular Assist Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03369938
• Other study ID #: Ex-VAD
• Status: Completed
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• exercise training intervention
structured aerobic endurance/resistance training on top of usual care for 12 weeks (3x/week)

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin und Deutsches Herzzentrum Berlin	Berlin
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Herzzentrum Leipzig	Leipzig
Germany	Klinikum rechts der Isar der Technischen Universität München und Klinikum der Universität München	München

Sponsors (6)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Technische Universität München, University Medicine Greifswald, University of Göttingen, University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adherence to exercise training	accelerometry	up to 12 weeks of treatment
Primary	change in maximal exercise capacity	cardiopulmonary exercise testing (CPET; peakVO2)	after 12 weeks of treatment
Secondary	change in ventilatory efficacy	cardiopulmonary exercise testing (CPET; VE/VCO2 slope)	after 12 weeks of treatment and 12 weeks of follow-up
Secondary	change in submaximal exercise tolerance	6-minute-walk distance (m), anaerobic threshold (VO2 at AT)	after 12 weeks of treatment and 12 weeks of follow-up
Secondary	change in muscle strength	handgrip (kg)	after 12 weeks of treatment and 12 weeks of follow-up
Secondary	change in body composition	% fat mass	after 12 weeks of treatment and 12 weeks of follow-up
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ)	patient-reported measure of quality of life for patients with heart failure	after 12 weeks of treatment and 12 weeks of follow-up
Secondary	36-Item Short Form Survey (SF-36)	patient-reported measure of health status	after 12 weeks of treatment and 12 weeks of follow-up
Secondary	Patient Health Questionnaire (PHQ-9)	patient-reported measure of presence and severity of depression	after 12 weeks of treatment and 12 weeks of follow-up
Secondary	change in echocardiographic parameters of cardiac morphology and function at rest and during exercise	left ventricular ejection fraction (%)	after 12 weeks of treatment and 12 weeks of follow-up
Secondary	change in echocardiographic parameters of cardiac morphology and function at rest and during exercise	left ventricular end diastolic volume (ml)	after 12 weeks of treatment and 12 weeks of follow-up
Secondary	change in echocardiographic parameters of cardiac morphology and function at rest and during exercise	left ventricular end diastolic diameters (mm)	after 12 weeks of treatment and 12 weeks of follow-up
Secondary	change in echocardiographic parameters of cardiac morphology and function at rest and during exercise	tricuspid annular plane systolic excursion (TAPSE; mm)	after 12 weeks of treatment and 12 weeks of follow-up
Secondary	change in markers of neuroendocrine activation	NT-proBNP (ng/l)	after 12 weeks of treatment and 12 weeks of follow-up
Secondary	change in daily physical activity	physical activity diary	up to 12 weeks of treatment and 12 weeks of follow-up
Secondary	change in daily physical activity	accelerometry	up to 12 weeks of treatment and 12 weeks of follow-up

External Links

•   Ex-VAD trial website