Design of the cardiac insufficiency bisoprolol study II (OBIS II)

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Abstract
Summary— Clinical research in chronic heart failure has recently focused on the stimulated neuro‐hormonal compensatory mechanisms that could contribute to auto‐aggravation of the disease. On the basis of such a hypothesis, 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 of beta‐adrenoceptor blockade induced benefit on survival remains to be demonstrated. On the basis of CIBIS I data, the objective of the Cardiac Insufficiency Bisoprolol Study II (CIBIS II) is to evaluate effects of the selective beta‐1 adrenoceptor blocker, bisoprolol, on mortality (primary endpoint) in patients with ischaemic or non‐ischaemic chronic heart failure. Eligible patients will be symptomatic ambulatory patients with left ventricular ejection fraction ≤ 35% in NYHA functional class III or IV, receiving a background treatment of diuretics and angiotensin converting enzyme inhibitors. A total of 2,500 patients are planned to be included with a mean follow up of at least 3 years. Secondary endpoints include hospitalisations, cardiovascular mortality and combination of both as well as permanent treatment 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 beta‐adrenoceptor blockade induced benefit with bisoprolol in chronic heart failure.