6/28/23, 12:09 AM CIBIS Pathway Feedback Search Clinical Topics Home Studies CIBIS CIBIS Disease Heart failure Trial question What is the role of -blockade therapy with bisoprolol in patients with chronic HF of various etiologies and a LVEF of < 40% on diuretic and vasodilator therapy? Study design Multi-center Double blinded RCT Population Characteristics of study participants 17.0% female N = 641 83.0% male 641 patients (112 female, 529 male) Inclusion criteria: patients with chronic HF of various etiologies and an LVEF < 40% on diuretic and vasodilator therapy Key exclusion criteria: LV diastolic dysfunction, coronary heart disease awaiting bypass surgery or a recent history of myocardial infarction < 3 months, insulin-dependent diabetes, asthma, renal insufficiency hypothyroidism or hyperthyroidism, or malignant disease Interventions N=320 -blockade therapy with bisoprolol (recommended dose increment or at one of the dose levels of 1.25, 2.5, 3.75, or 5 mg/d) N=321 placebo (matching placebo) Primary outcome Death https://web.pathway.md/studies/recEklJnj1TGOez9x 1/2 6/28/23, 12:09 AM CIBIS Pathway 20.9 % 20.9 16.6 15.7 % 10.4 % 5.2 % No significant difference 0.0 % Beta-blockade therapy with bisoprolol Placebo No significant difference in death (16.6% vs. 20.9%; RR 0.8, 95% CI 0.56 to 1.15) Secondary outcomes Significant decrease in hospitalization for cardiac decompensation (19.1% vs. 28%; RR 0.68, 95% CI 0.16 to 1.2) Significant increase in reduction by at least one NYHA functional class (21.3% vs. 15%; RR 1.42, 95% CI 0.06 to 2.78) Safety outcomes No significant difference in premature treatment withdrawals. Conclusion In patients with chronic HF of various etiologies and an LVEF < 40% on diuretic and vasodilator therapy, -blockade therapy with bisoprolol was not superior to placebo with respect to death. Reference CIBIS Investigators. A randomized trial of beta-blockade in heart failure. The Cardiac Insufficiency Bisoprolol Study (CIBIS). CIBIS Investigators and Committees. Circulation. 1994 Oct;90(4):1765-73. Open reference URL https://web.pathway.md/studies/recEklJnj1TGOez9x 2/2