STUDIES OF LEFT VENTRICULAR DYSFUNCTION

这份合同是为一家临床中心签订的，该中心是 将在左侧进行大规模临床试验的25个中心 心功能不全。这项试验的主要目标是回答 两个问题： (1)在中度左心功能不全且很少或没有的患者 明目张胆的心力衰竭，死亡能预防吗？ (2)明显心力衰竭患者的死亡率是否通过治疗而降低？ 两项同时进行但截然不同的随机双盲对照试验将 被引导了。第一个将是预防试验，将是安慰剂 控制住了。第二个将是治疗试验，患者将 随机接受标准治疗安慰剂或标准治疗 现役特工。预防试验的预计登记人数为 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.