EFFECT OF AMLODIPINE ON SURVIVAL IN PATIENTS WITH CONGESTIVE HEART FAILURE

本研究的主要目的是比较 与安慰剂联合治疗对中度脑梗死患者全因死亡率的影响 治疗的非缺血性病因的重度心力衰竭（NYHA III-IV级） 血管紧张素转换酶抑制剂地高辛和利尿剂此外，亚组 主要终点分析：NYHA III级vs. IV级;基线LVEF 中位数以上和以下;年龄;和性别将进行。的 随机、双盲、多中心研究将在240 美国和加拿大境内的研究中心，每个研究中心都为 至少8名患者，总计约1800名患者。它 将包括筛选访视，然后是双盲期， 最长3年;持续时间由招募率、事件 率和停止规则。研究将继续进行，直至 安慰剂组264例死亡。

The primary objective of this study is to compare the effect of Amlodipine with placebo on all-cause mortality in patients with moderate to severe heart failure (NYHA III-IV) of non-ischemic etiology treated with ACE inhibitors, digoxin and diuretics. Additionally, subgroup analyses of the primary endpoint: NYHA class III vs. IV; baseline LVEF above and below the median; age; and gender will be conducted. The randomized, double-blind multicenter study will be conducted at 240 sites within the United States and Canada, with each center contributing a minimum of 8 patients for a total of approximately 1800 patients. It will consist of a screening visit, followed by a double-blind period of up to 3 years; duration to be determined by the recruitment rate, event rate and stopping rules. The study will continue until the occurrence of 264 deaths in the placebo group.