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TP 12 Multicenter Trials

Background

Drug treatment for heart failure has undergone a fundamental transformation in the past 20 years. Today, beta blockers are indispensable. Their use is recommended by national and international specialist associations for all patients, regardless of age. Elderly patients are the largest group with heart failure: 90 percent of patients with heart failure are over 65 years of age. However, due to fear of side effects with multiple accompanying medications and comorbidity, This treatment is frequently withheld from elderly patients in particular. The situation is made more difficult by the fact that the average age of study patients has traditionally not reflected the older age of the population under investigation.

Objective

We developed an internationally recognized study group – „Multicentric Heart Failure Therapy Studies“ – with good organizational structures. The study groups are composed of staff members from the centers collaborating with the competence network and involve experts from all subspecialties in cardiology, cardiovascular surgery, biometrics and statistics. The purpose of this is to substantially improve the quality of clinical therapy studies in the area of heart failure.

Key Results

Careful up-titration of betablocker therapy is necessary for older patient populations. In the controlled randomized CIBIS-ELD trial (883 Patients), bisoprolol lead to greater decreases in heart rate and was better tolerated by patients with pulmonary comorbidities compared with carvedilol. Self-rated quality of life was a predictor of adverse events in heart failure patients.

Publications

  • Düngen HD et al. Titration to target dose of bisoprolol vs. carvedilol in elderly patients with heart failure: the CIBIS-ELD trial. Eur J Heart Fail. 2011;13:670-80.
  • Lainscak M et al. Self-rated health predicts adverse events during beta-blocker treatment: the CIBIS-ELD randomized trial analysis. Int J Cardiol. 2011 Jun 6. [Epub ahead of print].
  • Gelbrich G et al. Is target dose the treatment target? – Uptitrating beta-blockers for heart failure in the elderly. Int J Cardiol. 2012;155:160-6.

Outlook

A multinational, multidisciplinary research network of hospitalists, general physicians and cardiologists, coordinated by the heart failure study center at the Charité, is now equipped to implement and efficiently manage future publically and privately funded multicenter clinical trials (such as BIOSTAT-CHF, MOLITOR, ETICS, Ex-DHF).

Contakt

PD Dr. Hans-Dirk Düngen
Charité – Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Kardiologie
Tel.: +49 (0)30 450676818
E-Mail: ed.etirahcnull@negneud.krid-snah