DESIGN OF THE CARDIAC-INSUFFICIENCY BISOPROLOL STUDY-II (CIBIS-II)

Clinical research in chronic heart failure has recently focused on the stimulated neuro-hormonal compensatory mechanisms that could contribu te to auto-aggravation of the disease. On the basis of such a hypothes is, and apart from the inhibition of the renin angiotensin system, the antagonism of beta-receptors has evolved as a promising approach for improving quality of life and prognosis. However, the definite proof o f beta-adrenoceptor blockade induced benefit on survival remains to be demonstrated. On the basis of CIBIS I data, the objective of the Card iac Insufficiency Bisoprolol Study II (CIBIS II) is to evaluate effect s of the selective beta-1 adrenoceptor blocker, bisoprolol, on mortali ty (primary endpoint) in patients with ischaemic or non-ischaemic chro nic heart failure. Eligible patients will be symptomatic ambulatory pa tients with left ventricular ejection fraction less than or equal to 3 5% in NYHA functional class III or IV, receiving a background treatmen t of diuretics and angiotensin converting enzyme inhibitors. A total o f 2,500 patients are planned to be included with a mean follow up of a t least 3 years. Secondary endpoints include hospitalisations, cardiov ascular mortality and combination of both as well as permanent treatme nt withdrawal. Bisoprolol will be titrated up to 10 mg, starting with 1.25 mg daily. Randomization began in November 1995. CIBIS II results will represent a basis for definite conclusions on the evaluation of b eta-adrenoceptor blockade induced benefit with bisoprolol in chronic h eart failure.