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


OBJECTIVE
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 >or=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.


CONCLUSIONS
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.
Department of Cardiology, Competence Network Heart Failure, Campus Virchow-Klinkum, Charité-Universitätsmedizin, Berlin, Germany. hans-dirk.duengen@charite.de
Hans-Dirk
HD
Düngen
Svetlana
S
Apostolović
Simone
S
Inkrot
Elvis
E
Tahirović
Florian
F
Krackhardt
Milan
M
Pavlović
Biljana
B
Putniković
Mitja
M
Lainscak
Götz
G
Gelbrich
Frank
F
Edelmann
Rolf
R
Wachter
Thomas
T
Eschenhagen
Finn
F
Waagstein
Ferenc
F
Follath
Mathias
M
Rauchhaus
Wilhelm
W
Haverkamp
Karl-Josef
KJ
Osterziel
Rainer
R
Dietz
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D017677:Age Distribution; D000368:Aged; D017298:Bisoprolol / Q000627:therapeutic use*; D002227:Carbazoles / Q000627:therapeutic use*; D000077261:Carvedilol; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000453:epidemiology*; D006801:Humans; D008297:Male; D011412:Propanolamines / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D016896:Treatment Outcome
D000319:Adrenergic beta-Antagonists; D002227:Carbazoles; D011412:Propanolamines; D000077261:Carvedilol; D017298:Bisoprolol