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Bisoprolol vs. carvedilol in elderly patients with heart failure: rationale and design of the CIBIS-ELD trial

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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.

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Author information

Authors and Affiliations

  1. Competence Network Heart Failure, Campus Virchow-Klinkum, Department of Cardiology, Charité-Universitätsmedizin, Augustenburger Platz 1, 13353, Berlin, Germany

    Hans-Dirk Düngen, Simone Inkrot, Elvis Tahirović, Florian Krackhardt, Mathias Rauchhaus, Wilhelm Haverkamp & Rainer Dietz

  2. Department of Cardiology, Clinical Center Niš, Bulevar Dr. Zorana Djindjica 48, 18000, Nis, Serbia

    Svetlana Apostolović & Milan Pavlović

  3. Department of Cardiology, University Hospital Zemun, Vukova 9, 11080, Belgrade, Serbia

    Biljana Putniković

  4. University Clinic for Pulmonary and Allergic Diseases Golnik, Golnik 36, 4204, Golnik, Slovenia

    Mitja Lainščak

  5. Coordination Center for Clinical Trials Leipzig, Haertelstr. 16-18, 04107, Leipzig, Germany

    Götz Gelbrich

  6. Department of Cardiology, Georg-August-Universitaet Göttingen, Robert Koch Str. 40, 37075, Göttingen, Germany

    Frank Edelmann & Rolf Wachter

  7. Institute for Experimental and Clinical Pharmacology, Hamburg University Hospital, Martinistr. 52, 20146, Hamburg, Germany

    Thomas Eschenhagen

  8. Department of Molecular and Clinical Medicine/Cardiology, Wallenberg Laboratory for Cardiovascular Research, Sahlgrenska Academy at Göteborg University, 413 45, Göteborg, Sweden

    Finn Waagstein

  9. Department of Internal Medicine, University Hospital, Rämistrasse 71, 8006, Zürich, Switzerland

    Ferenc Follath

  10. Private Practice for Internal Medicine and Cardiology, Marienstr. 9, 92224, Amberg, Germany

    Karl-Josef Osterziel

Authors
  1. Hans-Dirk Düngen
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  2. Svetlana Apostolović
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  3. Simone Inkrot
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  4. Elvis Tahirović
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  5. Florian Krackhardt
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  6. Milan Pavlović
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  7. Biljana Putniković
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  8. Mitja Lainščak
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  9. Götz Gelbrich
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  10. Frank Edelmann
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  11. Rolf Wachter
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  12. Thomas Eschenhagen
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  13. Finn Waagstein
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  14. Ferenc Follath
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  15. Mathias Rauchhaus
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  16. Wilhelm Haverkamp
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  17. Karl-Josef Osterziel
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  18. Rainer Dietz
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Consortia

on behalf of the CIBIS-ELD investigators, subproject “Multicenter Trials” in the Competence Network Heart Failure

Corresponding author

Correspondence to Hans-Dirk Düngen.

Additional information

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 http://www.controlled-trials.com.

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Düngen, HD., Apostolović, S., Inkrot, S. et al. Bisoprolol vs. carvedilol in elderly patients with heart failure: rationale and design of the CIBIS-ELD trial. Clin Res Cardiol 97, 578–586 (2008). https://doi.org/10.1007/s00392-008-0681-6

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  • DOI: https://doi.org/10.1007/s00392-008-0681-6

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