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Bisoprolol vs. carvedilol in elderly patients with heart failure: rationale and design of the CIBIS-ELD trial
Authors:Hans-Dirk?Düngen  Svetlana?Apostolovi?  Simone?Inkrot  Elvis?Tahirovi?  Florian?Krackhardt  Milan?Pavlovi?  Biljana?Putnikovi?  Mitja?Lain??ak  G?tz?Gelbrich  Frank?Edelmann  Rolf?Wachter  Thomas?Eschenhagen  Finn?Waagstein  Ferenc?Follath  Mathias?Rauchhaus  Wilhelm?Haverkamp  Karl-Josef?Osterziel  Rainer?Dietz
Affiliation:1.Competence Network Heart Failure, Campus Virchow-Klinkum, Department of Cardiology,Charité-Universit?tsmedizin,Berlin,Germany;2.Department of Cardiology,Clinical Center Ni?,Nis,Serbia;3.Department of Cardiology,University Hospital Zemun,Belgrade,Serbia;4.University Clinic for Pulmonary and Allergic Diseases Golnik,Golnik,Slovenia;5.Coordination Center for Clinical Trials Leipzig,Leipzig,Germany;6.Department of Cardiology,Georg-August-Universitaet G?ttingen,G?ttingen,Germany;7.Institute for Experimental and Clinical Pharmacology,Hamburg University Hospital,Hamburg,Germany;8.Department of Molecular and Clinical Medicine/Cardiology, Wallenberg Laboratory for Cardiovascular Research,Sahlgrenska Academy at G?teborg University,G?teborg,Sweden;9.Department of Internal Medicine,University Hospital,Zürich,Switzerland;10.Private Practice for Internal Medicine and Cardiology,Amberg,Germany
Abstract:Background  Chronic heart failure (CHF) is a widespread disease with severe quality of life impairment and a poor prognosis. Beta-blockers are the mainstay of CHF therapy; yet they are under-prescribed and under-dosed in clinical practice. This is particularly evident in elderly patients, which may be due to a fear of side-effects or intolerance. Beta-blockers have further not been adequately tested in patients with diastolic CHF, which is particularly common in elderly patients. Finally, comparative data on the use of different beta-blockers in patients with CHF is scarce. Aim  To compare the tolerance of bisoprolol and carvedilol in elderly patients with CHF. Methods  CIBIS-ELD is an investigator-initiated, multi-centre, 1:1 randomised, double-blind, phase III trial comparing bisoprolol and carvedilol in patients ≥65 years with systolic or diastolic CHF. Recruitment started in April 2005 and is anticipated to be completed by April 2008 with at least 800 patients enrolled. Perspective  This is the first large scale head to head beta-blockers trial in an elderly population with CHF. Besides determining which of two standard beta-blockers is best tolerated in elderly patients with systolic or diastolic CHF, we expect to gain further insight into the treatment of the particular population of patients with diastolic CHF. This trial was supported by the Competence Network of Heart Failure funded by the Federal Ministry of Education and Research (BMBF, project number 01GI0205) and is registered with number ISRCTN34827306 at .
Keywords:chronic heart failure  bisoprolol  carvedilol  tolerance  head-to-head
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