Clinical Study Center
Our Clinical Study Center (CRU) specializes in cardiovascular disease, diabetes and obesity and has a track record in competitive, high-volume subject recruitment and retention.
Our mission is to promote health in patients with cardiovascular disease and the translation of innovation in medical research into patient care. We strive to improve outcomes, increase cardiovascular health, and promote quality of life and independence for our patients.
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Our CRU integrates primary, secondary and tertiary patient care within clinical research on the outpatient level. Our highly qualified team of dedicated full-time clinical research cardiologists, internists, residents and study nurses participates in the full range of patient care. They are trained and educated on a regulatory basis following a unique clinical research curriculum.
Our facility has complete access to an ultra-high spectrum of disease entities at Charité – Universitätsmedizin Berlin, one of Europe's largest university medical providers. We partner with a whole range of academic and non-academic research institutions such as the Berlin Institute of Health (BIG/BIH), and the German Centre for Cardiovascular Research (DZHK/GCCR).
Aside from pharmaceutical compounds and medicinal products we investigate life-style interventions, exercise interventions, nutritional and educational interventions among others.
Our CRU is highly experienced in hands-on Phase IIa, Phase IIb, Phase III and Phase IV pharmaceutical and nonpharmaceutical trials on site. Optional in-patient hospitalization within Phase IIa/IIb studies can be organized. Biomaterial sample handling, storage, biobanking, and shipment are part of our routine and follow international standards. Ultra-deep-freezing storage (-20°C, -80°C) is available. We strictly follow ICH/GCP requirements, follow in-house standard operating procedures (SOP) and have implemented BIG/BIH, DZHK/GCCR and industry SOPs. Quality assessment and quality assurance, transparency and reproducibility of our results are a key asset of our CRU. We are active participants in the monitoring and auditing process and fully collaborate with the institutional review boards, regulatory offices and other in-house and external CRUs.
We routinely work with paper-based as well as full-electronic document filing, implement all established eCRF systems and can provide customized databases. Data security, data protection and privacy regulations are strictly implemented. Cost effectiveness of clinical research in the academic medical setting is incorporated at all times.
Emergency facilities such as AED/defibrillators, emergency carts, well-trained on-site staff and timely access to the in-house emergency room, rapid access to our resuscitation team and prompt admission to intensive care are provided at the highest level.
Our Clinical Study Center is a >350 sqm / >3700 sft facility consisting of 10 rooms for patient work-up, clinics, workspace, biomaterial processing and storage.
Our diagnostic toolkit includes, but is not limited to
- height, weight, BMI, BSA
- RR, ECG, physical examination
- laboratory workup (local & biobanking for blood, urine, saliva, stool, tissues, hair)
- long-term ECG, long-term blood pressure monitoring, HFV, ABI
- pulse wave analysis & non-invasive hemodynamics (SphygmoCor, Endopat, Vascular Explorer)
- invasive hemodynamics (right –heart catheter uni & stress test)
- ultrasonography (vascular, abdomen) & echocardiography (TTE, TEE)
- stress echo (dobumatine, bicycle)
- body composition analysis (DXA scan, BIA, BodPod)
- resting calorimetry
- cardiopulmonary exercise testing (CPET, spiroergometry, ergometry, 6MWT, SWT)
- lung function testing (body plethymosgraphy, CO diffusion, spirometry)
- questionnaires (SRH, QoL, SF-36, MLWHF, EQ5D, WHO)
- funcitonal capacity (SPPB, stand up to go, chair rising, hand grip)
BETA3_LVH: A multi-center randomized, placebo-controlled trial of mirabegron, a new beta3-adrenergic receptor agonist on the progression of left ventricular mass and diastolic function in patients with structural heart disease (NCT02599480)
HOMAGE: Bioprofiling response to mineralocorticoid receptor antagonists for the prevention of heart failure. A proof of concept clinical trial within the EU FP 7 (European Union FP7) "HOMAGE" program " Heart OMics in AGing "(NCT02556450)
SPIRIT-DHF: SPIRonolactone In the treatment for diastolic heart failure (DZHK)
TIM-HF II: Telemedical interventional management in heart failure II (TIM-HF II) (NCT01878630)
TORCH: German Centre for Cardiovascular Research Cardiomyopathy Register (TORCH) (DZHK) (NCT02187263)
Transition CHF: Systolic dysfunction to congestive heart failure cohort study (TransitionCHF) (DZHK) Key Publications (max. 10, nicht älter als 3-4 Jahre)
Effect of vericiguat, a soluble guanylate cyclase stimulator, on natriuretic peptide levels in patients with worsening chronic heart failure and reduced ejection fraction: The SOCRATES-REDUCED randomized trial. Gheorghiade M, Greene SJ, Butler J, Filippatos G, Lam CS, Maggioni AP, Ponikowski P, Shah SJ, Solomon SD, Kraigher-Krainer E, Samano ET, Müller K, Roessig L, Pieske B; SOCRATES-REDUCED Investigators and Coordinators. JAMA. 2015 Dec 1;314(21):2251-62. doi: 10.1001/jama.2015.15734.
Plasma mid-regional pro-adrenomedullin levels are inversely associated with anxiety but unrelated to depression: Results from the observational DIAST-CHF study in patients with cardiovascular risk factors. Meyer T, Herrmann-Lingen C, Chavanon ML, Pieske B, Wachter R, Edelmann F. Psychoneuroendocrinology. 2015 Dec;62:227-32. doi: 10.1016/j.psyneuen.2015.08.007. Epub 2015 Aug 13.
Galectin-3 in patients with heart failure with preserved ejection fraction: results from the Aldo-DHF trial. Edelmann F, Holzendorf V, Wachter R, Nolte K, Schmidt AG, Kraigher-Krainer E, Duvinage A, Unkelbach I, Düngen HD, Tschöpe C, Herrmann-Lingen C, Halle M, Hasenfuss G, Gelbrich G, Stough WG, Pieske BM. Eur J Heart Fail. 2015 Feb;17(2):214-23. doi: 10.1002/ejhf.203. Epub 2014 Nov 24.
Effect of spironolactone on diastolic function and exercise capacity in patients with heart failure with preserved ejection fraction: the Aldo-DHF randomized controlled trial. Edelmann F, Wachter R, Schmidt AG, Kraigher-Krainer E, Colantonio C, Kamke W, Duvinage A, Stahrenberg R, Durstewitz K, Löffler M, Düngen HD, Tschöpe C, Herrmann-Lingen C, Halle M, Hasenfuss G, Gelbrich G, Pieske B; Aldo-DHF Investigators.
Exercise training improves exercise capacity and diastolic function in patients with heart failure with preserved ejection fraction: results of the Ex-DHF (Exercise training in Diastolic Heart Failure) pilot study. Edelmann F, Gelbrich G, Düngen HD, Fröhling S, Wachter R, Stahrenberg R, Binder L, Töpper A, Lashki DJ, Schwarz S, Herrmann-Lingen C, Löffler M, Hasenfuss G, Halle M, Pieske B. J Am Coll Cardiol. 2011 Oct 18;58(17):1780-91. doi: 10.1016/j.jacc.2011.06.054.