DYNAMIC CARDIOMYOPLASTY VS STANDARD THERAPY FOR CONGESTIVE HEART FAILURE

动态心肌成形术与充血性心力衰竭的标准治疗

• 批准号: 6274469
• 负责人: MICHAEL A ACKER
• 金额: $ 2.5万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-04-15 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6274469
• 关键词: body physical activity; clinical research; congestive heart failure; functional ability; heart disorder chemotherapy; heart surgery; human morbidity; human mortality; human subject; human therapy evaluation; outcomes research; quality of life

This is a prospective randomized, unblinded, parallell group, multicentered study designed to determine the safety and satisfactory operation of the dynamic cardiomyoplasty operation and stimulation system, as well as to study its effectiveness in improving the functional status and quality of patients with end-stage congestive heart failure. The system and operation will be considered safe if mortality and morbidity in the treatment group are no worse than in the control group, and the procedure will be considered effective if maximal and submaximal exercise improvement, quality of life, and New York Heart Association functional class are greater than a control group (standard medical treatment) outcomes.

这是一个前瞻性随机、非盲、平行组， 多中心研究旨在确定安全性和满意度 动力性心肌成形术及刺激 系统，并研究其在改善 终末期充血性心力衰竭患者的功能状态和质量 心衰 系统和操作将被视为安全， 治疗组的死亡率和发病率并不比对照组差。 对照组，如果最大值为 和次极量运动改善、生活质量和纽约心脏病 关联功能类大于对照组（标准 治疗）的结果。