RANDOMIZED EVALUATION OF MECHANICAL ASSISTANCE FOR CONGESTIVE HEART FAILURE

充血性心力衰竭机械辅助的随机评估

• 批准号: 6264848
• 负责人: LESLIE MILLER
• 金额: $ 4.48万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264848
• 关键词: auxiliary heart prosthesis; biomedical equipment safety; circulatory assist; clinical biomedical equipment; clinical research; congestive heart failure; evaluation /testing; hospital utilization; human subject; human therapy evaluation; quality of life

This is a multicenter, randomized clinical trial to evaluate the efficacy, safety and cost-effectiveness of a left ventricular assist device in the treatment of heart failure. Ten patients at the University of Minnesota with end-stage congestive heart failure will be randomized to either standard medical therapy (n=5) or a mechanical left ventricular assist device (n=5) and followed for two years. The primary end point is patient survival. Secondary end points are quality of life, hospitalization, and cost. Patients assigned to treatment with the mechanical left ventricular assist device will convalesce in the GCRC. Patients in both groups will be followed at monthly intervals as GCRC outpatients.

这是一项多中心、随机临床试验，旨在评估左心室辅助装置治疗心力衰竭的有效性、安全性和成本效益。 明尼苏达大学的 10 名终末期充血性心力衰竭患者将被随机分配接受标准药物治疗 (n=5) 或机械左心室辅助装置 (n=5)，并随访两年。 主要终点是患者的生存率。 次要终点是生活质量、住院治疗和费用。 接受机械左心室辅助装置治疗的患者将在 GCRC 中康复。 两组患者将作为 GCRC 门诊患者每月进行一次随访。