EFFECT OF AMLODIPINE ON SURVIVAL IN PATIENTS WITH CONGESTIVE HEART FAILURE

这项研究的主要目的是比较氨氯地平和安慰剂对使用血管紧张素转换酶抑制剂、地高辛和利尿剂治疗的中到重度心力衰竭(NYHA III-IV)患者的全因死亡率的影响。此外，还将进行主要终点的分组分析：NYHA III级与IV级；基线LVEF高于和低于中位数；年龄；以及性别。这项随机、双盲的多中心研究将在美国和加拿大的240个地点进行，每个中心至少贡献8名患者，总共约1,800名患者。它将包括一次筛查访问，然后是长达3年的双盲期；持续时间取决于招聘率、事故率和停止规则。这项研究将继续进行，直到安慰剂组发生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.