Back to resultsExercise Training in Patients With Left Ventricular Assist Device (Ex-VAD)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
exercise training intervention
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring left ventricular assist device, exercise training
Eligibility Criteria
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
Sites / Locations
- Charité - Universitätsmedizin Berlin und Deutsches Herzzentrum Berlin
- Universitätsklinikum Düsseldorf
- Universitätsklinikum Hamburg-Eppendorf
- Herzzentrum Leipzig
- Klinikum rechts der Isar der Technischen Universität München und Klinikum der Universität München
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
exercise training intervention
usual care
Arm Description
Outcomes
Primary Outcome Measures
change in maximal exercise capacity
cardiopulmonary exercise testing (CPET; peakVO2)
Secondary Outcome Measures
change in ventilatory efficacy
cardiopulmonary exercise testing (CPET; VE/VCO2 slope)
change in submaximal exercise tolerance
6-minute-walk distance (m), anaerobic threshold (VO2 at AT)
change in muscle strength
handgrip (kg)
change in body composition
% fat mass
Kansas City Cardiomyopathy Questionnaire (KCCQ)
patient-reported measure of quality of life for patients with heart failure
36-Item Short Form Survey (SF-36)
patient-reported measure of health status
Patient Health Questionnaire (PHQ-9)
patient-reported measure of presence and severity of depression
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
left ventricular ejection fraction (%)
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
left ventricular end diastolic volume (ml)
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
left ventricular end diastolic diameters (mm)
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
tricuspid annular plane systolic excursion (TAPSE; mm)
change in markers of neuroendocrine activation
NT-proBNP (ng/l)
change in daily physical activity
physical activity diary
change in daily physical activity
accelerometry
Full Information
NCT ID
NCT03369938
First Posted
November 15, 2017
Last Updated
January 26, 2021
Sponsor
Charite University, Berlin, Germany
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), University of Göttingen, University Medicine Greifswald, Technical University of Munich, University of Leipzig
1. Study Identification
Unique Protocol Identification Number
NCT03369938
Brief Title
Exercise Training in Patients With Left Ventricular Assist Device
Acronym
Ex-VAD
Official Title
Exercise Training in Patients With Left Ventricular Assist Device
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), University of Göttingen, University Medicine Greifswald, Technical University of Munich, University of Leipzig
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
left ventricular assist device, exercise training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise training intervention
Arm Type
Experimental
Arm Title
usual care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
exercise training intervention
Intervention Description
structured aerobic endurance/resistance training on top of usual care for 12 weeks (3x/week)
Primary Outcome Measure Information:
Title
change in maximal exercise capacity
Description
cardiopulmonary exercise testing (CPET; peakVO2)
Time Frame
after 12 weeks of treatment
Secondary Outcome Measure Information:
Title
change in ventilatory efficacy
Description
cardiopulmonary exercise testing (CPET; VE/VCO2 slope)
Time Frame
after 12 weeks of treatment and 12 weeks of follow-up
Title
change in submaximal exercise tolerance
Description
6-minute-walk distance (m), anaerobic threshold (VO2 at AT)
Time Frame
after 12 weeks of treatment and 12 weeks of follow-up
Title
change in muscle strength
Description
handgrip (kg)
Time Frame
after 12 weeks of treatment and 12 weeks of follow-up
Title
change in body composition
Description
% fat mass
Time Frame
after 12 weeks of treatment and 12 weeks of follow-up
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
patient-reported measure of quality of life for patients with heart failure
Time Frame
after 12 weeks of treatment and 12 weeks of follow-up
Title
36-Item Short Form Survey (SF-36)
Description
patient-reported measure of health status
Time Frame
after 12 weeks of treatment and 12 weeks of follow-up
Title
Patient Health Questionnaire (PHQ-9)
Description
patient-reported measure of presence and severity of depression
Time Frame
after 12 weeks of treatment and 12 weeks of follow-up
Title
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
Description
left ventricular ejection fraction (%)
Time Frame
after 12 weeks of treatment and 12 weeks of follow-up
Title
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
Description
left ventricular end diastolic volume (ml)
Time Frame
after 12 weeks of treatment and 12 weeks of follow-up
Title
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
Description
left ventricular end diastolic diameters (mm)
Time Frame
after 12 weeks of treatment and 12 weeks of follow-up
Title
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
Description
tricuspid annular plane systolic excursion (TAPSE; mm)
Time Frame
after 12 weeks of treatment and 12 weeks of follow-up
Title
change in markers of neuroendocrine activation
Description
NT-proBNP (ng/l)
Time Frame
after 12 weeks of treatment and 12 weeks of follow-up
Title
change in daily physical activity
Description
physical activity diary
Time Frame
up to 12 weeks of treatment and 12 weeks of follow-up
Title
change in daily physical activity
Description
accelerometry
Time Frame
up to 12 weeks of treatment and 12 weeks of follow-up
Other Pre-specified Outcome Measures:
Title
adherence to exercise training
Description
accelerometry
Time Frame
up to 12 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Charité - Universitätsmedizin Berlin und Deutsches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Herzzentrum Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universität München und Klinikum der Universität München
City
München
ZIP/Postal Code
80992
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://ex-vad.dzhk.de/
Description
Ex-VAD trial website
Learn more about this trial
Exercise Training in Patients With Left Ventricular Assist Device
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