STUDIES OF LEFT VENTRICULAR DYSFUNCTION

左心室功能障碍的研究

• 批准号: 3647092
• 负责人: JAMES B YOUNG
• 金额: $ 16.18万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-07-15 至 1991-10-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3647092
• 关键词: cardiotonic agents; cardiovascular disorder prevention; cooperative study; heart disorder; heart disorder chemotherapy; heart failure; heart ventricle; human mortality; human subject; human therapy evaluation

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.

该合同是为一个临床中心，这是一个估计 25个中心将进行大规模的临床试验 心室功能障碍 试验的主要目的是回答 两个问题： (1)中度左心室功能障碍且很少或没有左心室功能障碍的患者 心力衰竭，死亡可以预防吗？ (2)治疗是否能降低明显心力衰竭患者的死亡率？ 两项同时进行但不同的随机双盲对照试验将 进行。 第一个是预防试验，使用安慰剂 控制。 第二个将是治疗试验，患者将 随机分配至“标准”治疗+安慰剂或“标准”治疗+ 活性剂。 预防试验的预期入组人数为 至少4,000名患者和至少2,000名患者的治疗试验。