SUDDEN CARDIAC DEATH IN HEART FAILURE TRIAL

心力衰竭试验中的心源性猝死

• 批准号: 2457207
• 负责人: Gust Harry Bardy
• 金额: $ 60.11万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-05-01 至 2003-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2457207
• 关键词: amiodarone; arrhythmia; cardiovascular disorder chemotherapy; cardiovascular disorder epidemiology; clinical research; congestive heart failure; human subject; human therapy evaluation; implantable defibrillators; outcomes research; sudden cardiac death; therapy

Congestive heart failure (CHF) is a common and lethal disease. A new diagnosis of CHF is made in 400,000 Americans each year. Those with moderate left ventricular dysfunction have a death rate of 25% over 2 1/2 years, with 50% thought to be due to arrhythmias. The central hypothesis of this study is that amiodarone or an implantable cardioverter-defibrillator (ICD) will improve survival compared to placebo in patients with NYHA Class II and Class III CHF and reduced left ventricular ejection fraction, less than or equal to 35%. The study will be a prospective, clinical trial with 2,500 patients randomly allocated in equal proportions to three different treatment arms over 2 1/2 years. The first arm of the study will consist of conventional heart failure therapy and placebo. The second arm of the study will combine conventional therapy with amiodarone. The third arm of the study will employ conventional therapy with a pectoral ICD. Treatment arms will be compared using an intention-to-treat analysis. We have one primary specific aim: 1. To compare all cause mortality-based on a minimum of 2 1/2 years of follow-up in the three arms of the study. We have five secondary specific aims: 1. To determine the incidence of cardiac mortality and arrhythmic mortality, 2. To determine the incidence of VT/VF and profound bradyarrhythmias (rates less than or equal to 30 bpm) in CHF patients in the ICD arm via the ICD memory log, 3. To compare morbidity in each of the three arms of the study, 4. To compare health-related quality of life in the three arms of the study, 5. To compare cost of care for each treatment group and calculate incremental cost-effectiveness ratios for the two intervention arms. The study will be performed at 95 North American Institutions. The Clinical Coordinating Center is the University of Washington in Seattle while the Data Coordinating Center and the Economics and Quality of Life Coordinating centers are at Duke University. The ICD Memory Log Core Laboratory is a subunit of the Clinical Coordinating Center focusing on secondary specific aim #2.

充血性心力衰竭（CHF）是一种常见的致命疾病。 一个新 CHF的诊断每年在40万美国人中进行。 那些与 中度左心室功能障碍的死亡率为25％ 1/2年，认为50％是由于心律不齐。 中央 这项研究的假设是胺碘酮或可植入 有心脏逆转表纤颤器（ICD）将提高生存率 NYHA II类和III类CHF的患者的安慰剂 左心室射血分数，小于或等于35％。 该研究将是一项前瞻性临床试验，有2500名患者 以相等比例随机分配给三种不同的处理 超过2 1/2年的武器。 研究的第一臂将包括 常规的心力衰竭疗法和安慰剂。 第二臂 研究将将常规疗法与胺碘酮相结合。 第三臂 这项研究将采用常规疗法，并用胸腔ICD进行。 将使用意向性分析比较治疗臂。 我们有一个主要目标： 1。比较所有引起死亡率至少2 1/2年的死亡率 在研究的三个臂中进行后续。 我们有五个次要特定目标： 1。确定心脏死亡率和心律不齐的发生率 死亡， 2。确定VT/VF的发生率和深度心律不齐 （比率小于或等于30 bpm）ICD臂中的CHF患者通过 ICD内存日志， 3。为了比较研究三个臂的发病率， 4。比较与健康相关的生活质量 学习， 5。比较每个治疗组的护理成本并计算 两个干预臂的成本效益比增量。 该研究将在95个北美机构进行。 这 临床协调中心是西雅图华盛顿大学 数据协调中心以及生活的经济学和质量 协调中心在杜克大学。 ICD内存日志核心 实验室是关注临床协调中心的亚基 次要特定目标＃2。