Effects of losartan versus captopril on mortality in patients with symptomatic heart failure: Rationale, design, and baseline characteristics of patients in the Losartan Heart Failure Survival Study - ELITE II

Background: In the Evaluation of Losartan in the Elderly (ELITE) heart fail ure study, a survival benefit (primarily because of a reduction in sudden d eaths) was observed in symptomatic patients treated with losartan compared with captopril. Methods and Results: The Losartan Heart Failure Survival Study-ELITE II (cu rrently ongoing) is a double-blind, randomized clinical trial being conduct ed in 45 countries at 288 sites. ELITE LI formally tests the hypotheses tha t losartan, compared with captopril, will reduce all-cause mortality (prima ry end point) and sudden cardiac death and/or resuscitated cardiac arrest ( secondary end point). In addition, all-cause mortality and/or hospitalizati ons and cardiovascular mortality and/or hospitalizations will be evaluated. The trial has 90% power to detect a 25% treatment difference in all-cause mortality (event driven, 510 deaths). Substudies are examining quality of l ife, health care resource utilization, and mechanisms related to the reduct ion in sudden death. During recruitment (June 1997 to May 1998), 3,152 pati ents aged 60 years or older (mean age, 71.6 years), with New York Heart Ass ociation classes II (51%), III (44%), and IV (5%), and left ventricular eje ction fraction of 40% or less (mean, 31%) were randomized to receive either 12.5 mg of losartan, titrated as tolerated to 50 mg once daily, or 12.5 mg of captopril, titrated as tolerated to 50 mg thrice daily. Randomization w as stratified by clinical site and for baseline beta-blocker use. Conclusion: The ELITE II study will further define the role of losartan in the treatment of patients with symptomatic heart failure relative to the an giotensin-converting enzyme inhibitor captopril, an agent from a class curr ently considered standard treatment for this disease.