THE ATLAS STUDY (ASSESSMENT OF TREATMENT WITH LISINOPRIL SURVIVAL) JUSTIFICATION AND OBJECTIVES

Treatment with ACE inhibitors has improved the prognosis of cardiac fa ilure (CF). The results of CONSENSUS I, SOLVD and V HEFT II show clini cal improvement and longer survival with this therapeutic class of dru gs. However, the search for the optimal dosage was not undertaken in t hese trials (a standard dose was fixed at the onset, average dose of e nalapril from 15 to 20 mg/day). In clinical practice, patients are pre scribed lower doses of ACE inhibitors (enalapril : 7.5 mg/day) than th e averages used in large scale trials. In order to optimise the use of ACE inhibitors, the ATLAS study (Assessment of Treatment with Lisinop ril and Survival) was undertaken with the precise objective of compari ng two dosages (2.5 to 5 mg/day vs 32.5 to 35 mg/day) of lisinopril on the morbidity and mortality of patients with CF. This international, multicenter, randomised, double-blind parallel group trial aims to inc lude 3 000 patients over 18 years of age with NYHA Classes II, III and IV, and an ejection fraction less-than-or-equal-to 30 % and to follow them up for 3 to 4.5 years. Nearly 30 French centres will participate in this trial. After an initial, open period of evaluation of toleran ce (5 mg to 15 mg/day of lisinopril in France), the patients will be r andomised to two groups. After randomisation, all patients will receiv e 5 mg per day of lisinopril. The << high dose >> group will receive 2 0 mg/day for two weeks, then 30 mg/day in addition to the << open dosa ge >>. In cases of intolerance, the dosage may be reduced to 20 mg/day or 10 mg/day, or the drug may be withdrawn. The other group will rece ive (in addition to the << open >> dosage) a placebo with the same pro tocol of adjustment for these treatments. All patients will be followe d up for a minimum of 3 years. The criteria of assessment will be : mo rtality from all causes - Cardiovascular mortality subdivided into 1) sudden death 2) congestive cardiac failure 3) myocardial infarction 4) other cardiovascular causes - Cardiovascular morbidity - Cumulative c ardiovascular mortality and morbidity - Cumulative cardiovascular morb idity and << all cause >> mortality - Myocardial infarction - Infarcti on and hospital admission for unstable angina. The results of this stu dy should be available in 1997.