Ex-VAD-DZHK11


Study information
Ex-VAD-DZHK11

Recruiting status

Study completed

Recruitment start

12/2017

Patients

64

66

Clinical Trials Registration

NCT03369938

Category

Early clinical study

DZHK Funding

EUR 640.523,21

Links

https://ex-vad.dzhk.de/

Operative contact
Administrativ-coordinately:
Doris Bach
(Ex-VAD@dzhk.de)
medical-scientific:
Anna Bobenko, MD
Ex-VAD@dzhk.de

Studienzentren/Kontakt (PDF)

Exercise Training in Patients with Left Ventricular Assist Device (Ex-VAD-DZHK11)

The number of patients with an artificial heart has significantly risen in the last years because patients receive artificial heart implantations, a so-called left ventricular assist device, in order to bridge the waiting period until heart transplantation.

This study is examining whether a tailored physical exercise can improve the fitness and quality of life of patients with an artificial heart. Their surgery should date back at least three months. All patients participate in a moderate training program for twelve weeks: They train three times per week on a bicycle ergometer and after four weeks tailored strength training is added to their exercise plan. Alongside physical fitness, biomarkers in the blood and examinations of the heart function and structure the trial will also reveal how the study participant’s quality of life changes in the process. Furthermore, once the exercise phase is completed, the study participants will be regularly examined for further twelve weeks in order to measure long-term effects.

The hope is that the natural heart’s performance will also improve with this regular physical exercise, since the long-term goal is to strengthen the individual’s own heart in such a way that the artificial heart can be removed after a certain period of time. In addition to Berlin, the DZHK sites Hamburg and Munich are also participating in the pilot study. If the positive expectations of the scientists are confirmed, large-scale multi-centre studies must substantiate the effects of physical exercise before it can find its way into the treatment guidelines of these patient groups.

Publications

Exercise training in patients with a left ventricular assist device (Ex-VAD): rationale and design of a multicentre, prospective, assessor-blinded, randomized, controlled trial. Bobenko, A., Schoenrath, F., Knierim, J. H., Friede, T., Verheyen, N., Mehra, M. R., Haykowsky, M., Herrmann-Lingen, C., Duvinage, A., Pieske-Kraigher, E., Halle, M., Falk, V., Pieske, B. & Edelmann, F. European journal of heart failure. (2019)

All publications of the trial can be found here: Ex-VAD-DZHK11 publications.

Principal Investigators

Prof. Dr. Frank Edelmann
Charité - Universitätsmedizin Berlin
Prof. Dr. Volkmar Falk
Deutsches Herzzentrum Berlin (DHZB)
Univ. Prof. Dr. med. Burkert Pieske
Charité - Universitätsmedizin Berlin und Deutsches Herzzentrum Berlin (DHZB)
Martin Halle
Klinikum rechts der Isar der Technischen Universität München

Press releases and news

DZHK study: a better quality of life for patients with artificial hearts

The number of patients with an artificial heart has drastically risen in the last ten years. This...

Berlin,Leipzig,Hamburg,Düsseldorf,München

Study recruitment is available in these cities