Trial Site
We specialize in early phase and proof of concept studies in cardiology with a particular focus on heart failure. Our outstanding expertise and excellent infrastructure allow us to successfully implement even the most complex study protocols.
With our long-term experience in clinical trials and our large physician network that connects us to the different departments of the Charité we offer reliable inclusion in a broad variety of studies. Our team consists of specialized study nurses, study physicians and study coordinators in the field of cardiovascular studies.
Sie befinden sich hier:
In recent years we have built up a strong international network, primarily based in Eastern Europe (Croatia, Slovenia and Serbia), which allows us to easily access numerous university hospitals and other hospitals in this region. Performing clinical studies in these centers means prompt and unbureaucratic procedures at a comparatively low cost, short start-up times and fast recruitment. The investigators we cooperate with are internationally recognized scientists, with a strong presence in European societies. Through this network we have already carried out many trials initiated by scientific institutions and pharmaceutical and biotech companies.
Services
Our services include:
- assistance with protocol development
- strategies for patient recruitment
- study execution in our trial site and early phase unit
- study management
- site management
- monitoring
- assistance with result interpretation
- assistance with manuscript writing
We are highly experienced in hands-on Phase IIa, Phase IIb and Phase III pharmaceutical and nonpharmaceutical trials on site. Optionally, for phase IIa/IIb trials patients can be hospitalized on our early phase unit.
Facilities
Located in the Department of Internal Medicine, Division of Cardiology, we have a fully equipped trial infrastructure, including examination rooms, echocardiography laboratory, cardiopulmonary exercise testing, laboratories and meeting rooms. Our equipment and facilities are solely reserved for trial conduct.
Team
The team is led by associate professor Dr. Hans-Dirk Düngen. As a senior cardiologist of Charité Universitätsmedizin, Dr. Düngen has broad national and international experience in initiating and executing clinical studies in the field of cardiology and especially in heart failure trials. He is also the author of numerous scientific publications. In 2012, he completed his PhD in cardiology at the Charité, as well as an MBA in Health Care Management at the Berlin School of Economics and Law.
Elvis Tahirovic, MPH, MBA, is the project manager of Dr. Düngen's working group. He has extensive experience in the leadership and coordination of clinical trials. Due to his Serbian background, he has excellent contacts with the countries of former Yugoslavia. Mr. Tahirovic has a Master of Public Health and an MBA in Health Care Management.
Yvonne Saewe is the study nurse in Dr. Düngen's working group, with extensive experience in coordination of clinical trials in the field of heart failure.
Mesud Sacirovic is a medical doctor who is responsible for trial coordination and recruitment of the patients. He is enrolled as a doctoral student.
Biljana Tesic is a medical doctor, responsible for patient recruitment and for the trial coordination. She is currently preparing her doctoral project.
Sara Radenovic is responsible for scientific writing in the team. She holds a Master in Pharmacy, and is currently working on her doctorate.
Recent Trials (selection)
PARSiFAL – multiple dose study in heart failure of a partial adenosine A1 receptor (BAY 1067197). Dr. Düngen was national coordinating investigator and the Charité site best recruiter.
ClinicalTrials.gov Identifier: NCT0204023
Sponsor: Bayer
CUPID – efficacy and safety study of genetically targeted enzyme replacement therapy for advanced heart failure (MYDICAR – AAV1/SERCA2a).
ClinicalTrials.gov Identifier: NCT00454818
Sponsor: Celladon Corporation
COSMIC-HF – chronic oral study of myosin activation to increase contractility in heart failure (omecamtiv mecarbil).
ClinicalTrials.gov Identifier: NCT01786512
Sponsor: Amgen
CHIARA-MIA – single blind, multicenter pilot study to investigate the safety and tolerability of a 14 day oral treatment with different doses of the chymase inhibitor (BAY 1142524) in clinically stable patients with left-ventricular dysfunction after myocardial infarction. Dr. Düngen was national coordinating investigator and Charité site once again best recruiter.
ClinicalTrials.gov Identifier: NCT02452515
Sponsor: Bayer
VENICE – Vericiguat (BAY 1021189) drug-drug interaction with nitroglycerin in stable coronary artery disease patients.
ClinicalTrials.gov Identifier: NCT02617550
Sponsor: Bayer
AEGIS-I – Phase 2b study of CSL112 (Apolipoprotein A-I Infusion) in patients with acute myocardial infarction.
ClinicalTrials.gov Identifier: NCT02108262
Sponsor: CSL Behring
RELAX-AHF-2 – Efficacy, safety and tolerability of serelaxin when added to standard therapy in acute heart failure. During this trial, Dr. Düngen's study group closely collaborated with ER within Charité.
ClinicalTrials.gov Identifier: NCT01870778
Sponsor: Novartis Pharmaceuticals
PARAGON-HF – efficacy and safety of LCZ696 compared to valsartan, on morbidity and mortality in heart failure patients with preserved ejection fraction. Dr. Düngen is coordinating investigator in Germany.
ClinicalTrials.gov Identifier: NCT01920711
Sponsor: Novartis Pharmaceuticals
Key Publications
Greene SJ, Sabbah HN, Butler J, Voors AA, Albrecht-Küpper BE, Düngen HD, Dinh W, Gheorghiade M. Partial adenosine A1 receptor agonism: a potential new therapeutic strategy for heart failure. Heart Fail Rev. 2016 Jan;21(1):95-102.
Edelmann F, Musial-Bright L, Gelbrich G, Trippel T, Radenovic S, Wachter R, Inkrot S, Loncar G, Tahirovic E, Celic V, Veskovic J, Zdravkovic M, Lainscak M, Apostolović S, Neskovic AN, Pieske B, Düngen HD. Tolerability and Feasibility of Beta-Blocker Titration in HFpEF Versus HFrEF: Insights From the CIBIS-ELD Trial. JACC Heart Fail. 2016 Feb;4(2):140-9.
Loncar G, Tscholl V, Tahirovic E, Sekularac N, Marx A, Obradovic D, Veskovic J, Lainscak M, von Haehling S, Edelmann F, Arandjelovic A, Apostolovic S, Stanojevic D, Pieske B, Trippel T, Dungen HD. Should procalcitonin be measured routinely in acute decompensated heart failure? Biomark Med. 2015;9(7):651-9.
Düngen HD, Musial-Bright L, Inkrot S, Apostolović S, Edelmann F, Lainščak M, Sekularac N, Störk S, Tahirovic E, Tscholl V, Krackhardt F, Loncar G, Trippel TD, Gelbrich G. Heart rate following short-term beta-blocker titration predicts all-cause mortality in elderly chronic heart failure patients: insights from the CIBIS-ELD trial. Eur J Heart Fail. 2014 Aug;16(8):907-14.
Lainscak M, Farkas J, Inkrot S, Gelbrich G, Neskovic AN, Rau T, Tahirovic E, Töpper A, Apostolovic S, Haverkamp W, Herrmann-Lingen C, Anker SD, Düngen HD. Self-rated health predicts adverse events during β-blocker treatment: the CIBIS-ELD randomised trial analysis. Int J Cardiol. 2013 Feb 10;163(1):87-92.
Rau T, Düngen HD, Edelmann F, Waagstein F, Lainščak M, Dimković S, Apostolović S, Nešković AN, Haverkamp W, Gelbrich G, Eschenhagen T. Impact of the β1-adrenoceptor Arg389Gly polymorphism on heart-rate responses to bisoprolol and carvedilol in heart-failure patients. Clin Pharmacol Ther. 2012 Jul;92(1):21-8.
Contact
Chief Financial Officer, Lead Project manager
t: +49 30 450 665 473
f: +49 30 450 7 565 473
f: +49 173 5637737
