PROSPECTIVE RANDOMIZED AMLODIPINE SURVIVAL EVALUATION

PRAISE（前瞻性随机截肢生存评估）是一项 多中心、随机、安慰剂对照、双盲、平行试验 在105个中心进行。其目的是评价疗效 一种长效二氢吡啶类钙通道阻滞剂， 与安慰剂相比， 死亡）和危及生命的心脏事件 （IIIb-IV级心力衰竭。所有患者均接受了 ACE抑制剂、地高辛和利尿剂。 按心脏分层随机化 失败的病因是缺血性或非缺血性心肌病， 预先指定的。 主要终点是死亡和 心脏病事件。 次要终点为全因死亡率。 在缺血性分层中，猝死和泵衰竭具有可比性 在两个治疗臂中。 相比之下， 38%，泵故障减少了45%， 非缺血层 虽然死亡方式没有因治疗而异， 在缺血性患者中， 猝死和泵衰竭死亡。 PRAISE证明了钙拮抗剂是一种安全的钙拮抗剂 在任何病因的LV功能障碍患者中， 非缺血性病因的患者。PRAISE-2将是一项研究， 为了进一步研究糖尿病对患者死亡率的影响， 充血性心力衰竭，NYHA III-IV级，非缺血性病因。

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.