VAD-DZHK3


Study information
VAD-DZHK3

Recruiting status

Recruiting ongoing

Recruitment start

07/2015

Patients

86

200

Clinical Trials Registration

NCT02387112

Category

Guideline relevant study

DZHK Funding

EUR 3.102.028,87

Links

https://vad.dzhk.de/

Operative contact
Main study centre - Sabine Hübler, MD
shuebler@dhzb.de

Studienzentren/Kontakt (PDF)

Early versus emergency left ventricular assist device implantation in patients awaiting cardiac transplantation (VAD-DZHK3)

This study is expected to deliver guideline-relevant findings for the future treatment of patients with terminal heart failure, especially with regard to potential alternatives to heart transplantation. The initiators of the study have succeeded for the first time in securing the participation of all of Germany’s major heart transplantation and ventricular assist device (VAD) centres in this DZHK study.

The study was prompted by the fact that in spite of all efforts undertaken by policy-makers - brought about by a general lack of willingness to donate organs - the number of heart transplantations in Germany is still decreasing. This means that a steadily growing number of patients with terminal heart failure are faced with an ever declining number of donor organs.

It is a known fact that patients on the waiting list for a heart transplantation in Germany have an average waiting time of 17 months to transplantation; at present, even high priority patients have to wait an average of 100 days. Each year nearly 19 percent of patients die while waiting for a donor heart. Almost all of these patients have to be admitted to hospital again and again. Circulatory support systems known as ventricular assist devices (VAD) currently come into use when patients cannot be stabilised with medication. At the same time, significant advances have been made not only in mechanical circulatory support systems.

As yet, there is no generally recognised standard for the optimal time point for implantation of a VAD. Clinics make their decisions based on their own experience gained over years of practice. At the beginning of the VAD era, one waited literally until the last moment and patients were only fitted with a VAD at the point when, in many cases, other organs apart from the heart had also suffered irreversible damage. However, in recent years an increasing trend towards earlier implantation has been observed. The results of this development have been very encouraging. Meanwhile, patients are living well with a VAD system, sometimes for several years.

Experts believe that, compared to current treatment, patients benefit from early VAD implantation, especially in view of the mortality rate in patients waiting for a donor organ. Patients who receive a VAD at an early stage cope better with the VAD implantation procedure, spend less time in hospital during the waiting period, suffer fewer complications and have a better quality of life than patients waiting for a donor organ in the manner practised to date, and possibly undergoing VAD implantation at a later stage. It is also possible that in some patients who receive a VAD at an early stage the heart has not yet been damaged beyond repair and it can recover during treatment to such an extent that the VAD can be explanted and a heart transplantation would no longer be needed in the long term. This study aims to provide scientific evidence to test these hypotheses.

Alongside the VAD study, supplementary data is collected using the VAD register. The register gathers data on patients who qualified for the VAD study but do not want to participate in it. If these patients consent to participate in the VAD register, the data collected about them during routine treatment will be used for the register. By combining these “routine data” with data of the VAD study, even more valid results are expected regarding the question of the optimal treatment for patients with terminal heart failure who are waiting for a donor organ.

Please use the following link to get to the website of the study https://vad.dzhk.de/

Publications

There are no publications available yet.

Principal Investigators

Prof. Dr. Volkmar Falk
Deutsches Herzzentrum Berlin (DHZB)
Prof. Dr. Christoph Knosalla
Deutsches Herzzentrum Berlin (DHZB)
Prof. Dr. Gerd Hasenfuß
Universitätsmedizin Göttingen / Georg-August Universität
Prof. Dr. Tim Friede
Universitätsmedizin Göttingen / Georg-August-Universität

Press releases and news

First Clinical Trials at the German Centre for Cardiovascular Research

When should patients with heart failure receive a cardiac support system? Can a drug against...

Berlin,Hamburg,Kiel,Bad Nauheim,Heidelberg,München,Leipzig,Jena,Bad Oeynhausen,Hannover,Bad Krozingen,Göttingen,Magdeburg

Study recruitment is available in these cities