STUDIES OF LEFT VENTRICULAR DYSFUNCTION

该合同适用于一家临床中心，该中心是预计的临床中心之一 左边将进行大规模临床试验的25个中心 心室功能障碍。 试验的主要目的是回答 两个问题： (1) 中度左心功能不全且很少或没有左心室功能不全的患者 明显的心力衰竭，死亡可以预防吗？ (2) 明显心力衰竭患者的死亡率是否可以通过治疗降低？ 两项同时但不同的随机双盲对照试验将 进行。 第一个是预防试验，并且是安慰剂 控制。 第二个是治疗试验，患者将 随机接受“标准”治疗安慰剂或“标准”治疗 活性剂。 预防试验的预计注册人数为 至少 4,000 名患者和至少 2,000 名患者的治疗试验。

This contract is for a clinical center which is one of an estimated twenty-five centers that will conduct a large scale clinical trial on left ventricular dysfunction. The primary objective of the trial is to answer two questions: (1) In patients with moderate left ventricular dysfunction and little or no overt heart failure, can death be prevented? (2) Is mortality reduced by treatment in those with manifest heart failure? Two concurrent but distinct randomized double blind controlled trials will be conducted. The first will be the Prevention Trial and will be placebo controlled. The second will be the Treatment Trial and patients will be randomized to "standard" treatment + placebo or "standard" treatment + active agent. The Prevention Trial has an anticipated enrollment of at least 4,000 patients and the Treatment Trial of at least 2,000 patients.