PRAISE 2--EFFECT OF AMLODIPINE ON SURVIVAL IN PTS W/ CONGESTIVE HEART FAILURE

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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.