PROSPECTIVE RANDOMIZED AMLODIPINE SURVIVAL EVALUATION

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PRAISE (Prospective Randomized Amlodipine Survival Evaluation) was a multicenter, randomized, placebo-controlled, double-blind, parallel trial which was conducted at 105 centers. Its purpose was evaluate the efficacy of amlodipine, a long acting dihydropyridine calcium channel blocker compared with placebo on combined mortality (cardiac and non-cardiac deaths) and life-threatening cardiac events in patients with severe (class IIIb-IV heart failure. All patients were treated with an Ace-Inhibitor, digoxin, and diuretic. Stratified randomization by heart failure etiology, ischemic or nonischemic cardiomyopathy, was prespecified. The primary endpoint was a combination of death and cardiac morbid events. The secondary endpoint was all-cause mortality. In the ischemic stratum, sudden deaths and pump failures were comparable in the two treatment arms. In contrast, sudden deaths were reduced by 38% and pump failures were reduced by 45% by amlodipine in the nonischemic stratum. While the mode of death did not differ by treatment in the ischemic patients, amlodipine appeared to comparably reduce both sudden death and death from pump failure in the ninischemic patients. PRAISE demonstrates that amlodipine is a safe calcium antagonist to use in patients with LV dysfunction of any etiology, and will be of benefit to patients with non-ischemic etiology. PRAISE-2 will be a study designed to examine further the effects of amlodipine on mortality in patients with congestive heart failure, NYHA III-IV, of nonischemic etiology.