PROSPECTIVE RANDOMIZED EVALUATION OF DYNAMIC CARDIOMYOPLASTY

动态心肌成形术的前瞻性随机评估

• 批准号: 6218230
• 负责人: PETER H PAK
• 金额: $ 0.23万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 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/6218230
• 关键词: clinical research; clinical trials; electrostimulus; heart failure; heart surgery; human subject; human therapy evaluation; longitudinal human study

The sponsor stopped this trial in October 1998. This was done when it became clear that projected enrollment would not be achieved within a reasonable time frame. Neither patients nor their physicians were willing to be randomized to surgery versus medicine. The purpose of this study was to determine if dynamic cardiomyoplasty would improve functional status and quality of life when compared with medical therapy in patients with dilated cardiomyopathy and heart failure. Dynamic cardiomyoplasty is a novel surgical treatment in which the latissimus dorsi is wrapped around the heart and stimulated to contract with a pacemaker-like device. The surgery was first done in 1985. Initial data suggested that this form of surgery improved quality of life and left ventricular function in patients with heart failure due to dilated cardiomyopathy. The current study was initiated over 3 years ago. In this multi-center, randomized, unblinded, clinical trial, patients with symptomatic heart failure (NYHA Class II-III) due to dilated cardiomyopathy were randomized to surgery or medical therapy. Follow-up was for one year with the possibility of crossover from medical therapy to dynamic cardiomyoplasty at that time. The primary end-point was quality of life and functional status at 12 months. One patient was enrolled in this trial at Johns Hopkins. He underwent dynamic cardiomyoplasty and did well. The sponsor stopped the trial on October 30, 1998. Analysis of the data is on going. Preliminary data suggests no statistical difference in patients treated with cardiomyoplasty when compared to continued medical therapy in terms of 6 minute walk distance, quality of life questionnaire, NYHA class, or peak oxygen consumption. We have not used GCRC resources for this trial in several years.

赞助商于1998年10月停止了这项试验。这样做是因为很明显，预计的入学人数不会在合理的时间范围内实现。患者和他们的医生都不愿意被随机分为手术和药物两组。本研究的目的是确定与药物治疗相比，动态心肌成形术是否能改善扩张型心肌病并心力衰竭患者的功能状态和生活质量。动态心肌成形术是一种新型的外科治疗方法，它将背阔肌包裹在心脏周围，并通过类似起搏器的装置刺激其收缩。该手术于1985年首次进行。初步数据表明，这种手术形式改善了扩张型心肌病心衰患者的生活质量和左心功能。目前的研究是在3年多前开始的。在这项多中心、随机、非盲目的临床试验中，扩张型心肌病所致的症状性心力衰竭(NYHA II-III级)患者被随机分为手术或内科治疗。随访一年，有可能从药物治疗过渡到当时的动态心肌成形术。主要终点是12个月时的生活质量和功能状态。约翰霍普金斯大学的一名患者参加了这项试验。他接受了动态心肌成形术，并做得很好。赞助商于1998年10月30日停止了试验。对数据的分析正在进行中。初步数据显示，接受心肌成形术的患者与继续接受药物治疗的患者相比，在6分钟步行距离、生活质量问卷、NYHA分级或最高耗氧量方面没有统计学差异。我们已经有几年没有使用GCRC的资源进行这项试验了。