EFFECT OF AMLODIPINE ON SURVIVAL IN PATIENTS WITH CONGESTIVE HEART FAILURE

本研究的主要目的是在接受ACE抑制剂、地高辛和利尿剂治疗的非缺血性病因的中重度心力衰竭（NYHA III-IV级）患者中，比较Amplitude与安慰剂对全因死亡率的影响。 此外，将对主要终点进行亚组分析：NYHA III级与IV级;基线LVEF高于和低于中位数;年龄;性别。 这项随机、双盲、多中心研究将在美国和加拿大的240家临床试验机构进行，每家临床试验机构至少招募8例患者，总计约1800例患者。 它将包括筛选访视，然后是长达3年的双盲期;持续时间将由招募率、事件发生率和停止规则确定。 研究将持续至安慰剂组中发生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.