Heart FailureEx-VADNCT03369938
Exercise Training in Patients With Left Ventricular Assist Device
A study testing exercise training intervention in people with Heart Failure, run by Charite University, Berlin, Germany at 5 sites in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- exercise training intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 5 sitesGermany
- Study dates
- 4 Dec 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Charité - Universitätsmedizin Berlin und Deutsches Herzzentrum Berlin
Berlin, 13353
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Herzzentrum Leipzig
Leipzig, 04289
Klinikum rechts der Isar der Technischen Universität München und Klinikum der Universität München
München, 80992
About this study
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).
- Conditions
- Heart Failure
- Being tested
- exercise training intervention
- Keywords
- left ventricular assist device, exercise training
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise training interventionOther
structured aerobic endurance/resistance training on top of usual care for 12 weeks (3x/week)
| Study group | Role | What they receive |
|---|---|---|
| exercise training intervention | Experimental | Not described Receives: Other: exercise training intervention |
| usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in maximal exercise capacity
cardiopulmonary exercise testing (CPET; peakVO2)
Measured: after 12 weeks of treatment
Secondary outcomes (14)
change in ventilatory efficacy
cardiopulmonary exercise testing (CPET; VE/VCO2 slope)
Measured: after 12 weeks of treatment and 12 weeks of follow-up
change in submaximal exercise tolerance
6-minute-walk distance (m), anaerobic threshold (VO2 at AT)
Measured: after 12 weeks of treatment and 12 weeks of follow-up
change in muscle strength
handgrip (kg)
Measured: after 12 weeks of treatment and 12 weeks of follow-up
change in body composition
% fat mass
Measured: after 12 weeks of treatment and 12 weeks of follow-up
Kansas City Cardiomyopathy Questionnaire (KCCQ)
patient-reported measure of quality of life for patients with heart failure
Measured: after 12 weeks of treatment and 12 weeks of follow-up
36-Item Short Form Survey (SF-36)
patient-reported measure of health status
Measured: after 12 weeks of treatment and 12 weeks of follow-up
Patient Health Questionnaire (PHQ-9)
patient-reported measure of presence and severity of depression
Measured: after 12 weeks of treatment and 12 weeks of follow-up
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
left ventricular ejection fraction (%)
Measured: after 12 weeks of treatment and 12 weeks of follow-up
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
left ventricular end diastolic volume (ml)
Measured: after 12 weeks of treatment and 12 weeks of follow-up
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
left ventricular end diastolic diameters (mm)
Measured: after 12 weeks of treatment and 12 weeks of follow-up
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
tricuspid annular plane systolic excursion (TAPSE; mm)
Measured: after 12 weeks of treatment and 12 weeks of follow-up
change in markers of neuroendocrine activation
NT-proBNP (ng/l)
Measured: after 12 weeks of treatment and 12 weeks of follow-up
change in daily physical activity
physical activity diary
Measured: up to 12 weeks of treatment and 12 weeks of follow-up
change in daily physical activity
accelerometry
Measured: up to 12 weeks of treatment and 12 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start4 Dec 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), University of Göttingen, University Medicine Greifswald, Technical University of Munich, University of Leipzig
- Responsible party
- Principal investigator, Univ.-Prof. Dr. med. Frank Edelmann, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369938
- Sponsor's protocol ID
- Ex-VAD
- Acronym
- Ex-VAD
- Status last verified
- Jan 2021
- First submitted
- 15 Nov 2017
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training in Patients With Left Ventricular Assist Device
- ClinicalTrials.gov ID
- NCT03369938
- Acronym / sponsor ID
- Ex-VAD / Ex-VAD
- Conditions
- Heart Failure
- Keywords
- left ventricular assist device, exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), University of Göttingen, University Medicine Greifswald, Technical University of Munich, University of Leipzig
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise training intervention | Experimental | Other: exercise training intervention |
| usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- chronic end-stage systolic heart failure
- stable on left ventricular assist device, meaning
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise training interventionstructured aerobic endurance/resistance training on top of usual care for 12 weeks (3x/week) | Other | exercise training intervention |
Primary outcome
change in maximal exercise capacity
Time frame: after 12 weeks of treatment
cardiopulmonary exercise testing (CPET; peakVO2)
14 secondary outcomes
change in ventilatory efficacy
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in submaximal exercise tolerance
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in muscle strength
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in body composition
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
36-Item Short Form Survey (SF-36)
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
Patient Health Questionnaire (PHQ-9)
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in markers of neuroendocrine activation
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in daily physical activity
Time frame: up to 12 weeks of treatment and 12 weeks of follow-up
change in daily physical activity
Time frame: up to 12 weeks of treatment and 12 weeks of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Ex-VAD trial websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training intervention in people with Heart Failure, run by Charite University, Berlin, Germany at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in maximal exercise capacity (time frame: after 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.