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

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ClinicalTrials.gov Identifier: NCT03369938
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : January 27, 2021
Sponsor:
Collaborators:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
University of Göttingen
University Medicine Greifswald
Technische Universität München
University of Leipzig
Information provided by (Responsible Party):
Univ.-Prof. Dr. med. Frank Edelmann, 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).

Condition or disease Intervention/treatment Phase
Heart Failure Other: exercise training intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise Training in Patients With Left Ventricular Assist Device
Actual Study Start Date : December 4, 2017
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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

No Intervention: usual care



Primary Outcome Measures :
  1. change in maximal exercise capacity [ Time Frame: after 12 weeks of treatment ]
    cardiopulmonary exercise testing (CPET; peakVO2)


Secondary Outcome Measures :
  1. change in ventilatory efficacy [ Time Frame: after 12 weeks of treatment and 12 weeks of follow-up ]
    cardiopulmonary exercise testing (CPET; VE/VCO2 slope)

  2. change in submaximal exercise tolerance [ Time Frame: after 12 weeks of treatment and 12 weeks of follow-up ]
    6-minute-walk distance (m), anaerobic threshold (VO2 at AT)

  3. change in muscle strength [ Time Frame: after 12 weeks of treatment and 12 weeks of follow-up ]
    handgrip (kg)

  4. change in body composition [ Time Frame: after 12 weeks of treatment and 12 weeks of follow-up ]
    % fat mass

  5. Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: after 12 weeks of treatment and 12 weeks of follow-up ]
    patient-reported measure of quality of life for patients with heart failure

  6. 36-Item Short Form Survey (SF-36) [ Time Frame: after 12 weeks of treatment and 12 weeks of follow-up ]
    patient-reported measure of health status

  7. Patient Health Questionnaire (PHQ-9) [ Time Frame: after 12 weeks of treatment and 12 weeks of follow-up ]
    patient-reported measure of presence and severity of depression

  8. 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 ]
    left ventricular ejection fraction (%)

  9. 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 ]
    left ventricular end diastolic volume (ml)

  10. 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 ]
    left ventricular end diastolic diameters (mm)

  11. 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 ]
    tricuspid annular plane systolic excursion (TAPSE; mm)

  12. change in markers of neuroendocrine activation [ Time Frame: after 12 weeks of treatment and 12 weeks of follow-up ]
    NT-proBNP (ng/l)

  13. change in daily physical activity [ Time Frame: up to 12 weeks of treatment and 12 weeks of follow-up ]
    physical activity diary

  14. change in daily physical activity [ Time Frame: up to 12 weeks of treatment and 12 weeks of follow-up ]
    accelerometry


Other Outcome Measures:
  1. adherence to exercise training [ Time Frame: up to 12 weeks of treatment ]
    accelerometry



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369938


Locations
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Germany
Charité - Universitätsmedizin Berlin und Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Herzzentrum Leipzig
Leipzig, Germany, 04289
Klinikum rechts der Isar der Technischen Universität München und Klinikum der Universität München
München, Germany, 80992
Sponsors and Collaborators
Charite University, Berlin, Germany
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
University of Göttingen
University Medicine Greifswald
Technische Universität München
University of Leipzig
Additional Information:
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Responsible Party: Univ.-Prof. Dr. med. Frank Edelmann, Professor for Cardiovascular Prevention and Clinical Heart Failure Research, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03369938    
Other Study ID Numbers: Ex-VAD
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Univ.-Prof. Dr. med. Frank Edelmann, Charite University, Berlin, Germany:
left ventricular assist device
exercise training
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases