SUDDEN CARDIAC DEATH IN HEART FAILURE TRIAL- SCD-HeFT

心力衰竭试验中的心脏性猝死 - SCD-HeFT

• 批准号: 6561363
• 负责人: Gust Harry Bardy
• 金额: $ 34.22万
• 依托单位: SEATTLE INSTITUTE FOR CARDIAC RESEARCH
• 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 2004-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6561363
• 关键词: amiodarone; arrhythmia; cardiovascular disorder chemotherapy; cardiovascular disorder epidemiology; cardiovascular disorder therapy; clinical research; clinical trials; congestive heart failure; cooperative study; cost effectiveness; human mortality; human subject; human therapy evaluation; implantable defibrillators; longitudinal human study; medical implant science; outcomes research; patient oriented research; quality of life; sudden cardiac death

DESCRIPTION (provided by applicant): The objective of this proposal is to perform one additional year of follow-up data collection in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) in order to accrue the number of events required to preserve the power of the study. SCD-HeFT is a multicenter randomized clinical trial of prophylactic amiodarone or implantable defibrillator therapy versus conventional heart failure medical therapy in patients with Class II or Class III heart failure, an ejection fraction equal to or <0.35, and no previous sustained ventricular arrhythmias. NHLBI funding for the trial was awarded for a six-year period beginning May 1, 1997 and ending April 30, 2003. Patient enrollment in the trial began September 16, 1997, and was completed July 18, 2001, upon reaching the target enrollment of 2,500 patients (final enrollment is 2,521). Patient follow-up is on-going, and under present funding timelines, will have to be terminated by October 31, 2002 to allow time for closing out the trial, completing the study database, analyzing the data, and preparing the main trial reports before funding expires. In the original study plan, the six-year timeline for the trial included 2.5 years of patient recruitment and 2.5 years of subsequent follow-up. Despite a three-fold increase in the number of clinical sites, and numerous creative recruitment strategies, patient enrollment required nearly four years. If the original timeline for closing the study is maintained, the average length of follow-up will fall short of the originally planned average follow-up by at least one full year. The key concern is that the number of events required to achieve an appropriate level of statistical power will not have occurred. An additional year of follow-up will allow the study to accrue the number of events that are consistent with the original design of the trial, improve the precision for assessing the true effects of these interventions, and thereby provide the clinical and scientific community with therapeutic information urgently needed for the rapidly growing population of heart failure patients.

描述（由申请人提供）：该提案的目的是在心力衰竭试验中突然心脏病死亡（SCD-HEFT）进行另外一年的随访数据收集，以累积维护研究能力所需的事件数量。 SCD-HEFT是针对II或II类心力衰竭的患者的预防性胺碘酮或可植入的除颤器治疗与常规心力衰竭药物治疗的多中心随机临床试验，其射血分数等于或<0.35，并且没有以前的持续性心律失常。该试验的NHLBI资金从1997年5月1日开始，并于2003年4月30日终止于六年期间授予。试验的患者入学开始于1997年9月16日开始，并于2001年7月18日完成了2500名患者的目标入学率（最终入学率为2,521）。患者的随访正在进行中，根据目前的资助时间表，必须在2002年10月31日之前终止，以便有时间结束试验，完成研究数据库，分析数据并在资金到期之前准备主要的试验报告。 在最初的研究计划中，该试验的六年时间表包括2。5年的患者招募和2。5年的随后随访。尽管临床站点的数量增加了三倍，并且众多创意招募策略，但患者入学率仍需要将近四年。如果要保持研究的原始时间表，则随访的平均长度将降至最初计划的平均随访至少一年。关键问题是，将不会发生获得适当水平的统计能力所需的事件数量。 额外的一年随访将使研究能够累积与试验原始设计一致的事件数量，提高评估这些干预措施的真实影响的精确度，从而为临床和科学界提供急需的治疗信息，以迫切需要快速增长的心力衰竭患者。

项目成果

Expression of lung inducible nitric oxide synthase protein does not correlate with nitric oxide production in vivo in a pulmonary immune response against Cryptococcus neoformans.

肺诱导型一氧化氮合酶蛋白的表达与体内针对新型隐球菌的肺部免疫反应中一氧化氮的产生不相关。

• 发表时间: 1997
• 期刊: Journal of immunology (Baltimore, Md. : 1950)
• 作者: Lovchik,J;Lipscomb,M;Lyons,CR
• 通讯作者: Lyons,CR

Role of microvolt T-wave alternans in assessment of arrhythmia vulnerability among patients with heart failure and systolic dysfunction: primary results from the T-wave alternans sudden cardiac death in heart failure trial substudy.

• DOI: 10.1161/circulationaha.107.748962
• 发表时间: 2008-11-11
• 期刊: Circulation
• 影响因子: 37.8
• 作者: Gold MR;Ip JH;Costantini O;Poole JE;McNulty S;Mark DB;Lee KL;Bardy GH
• 通讯作者: Bardy GH

Unexpected deviation in circadian variation of ventricular arrhythmias: the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial).

• DOI: 10.1016/j.jacc.2013.11.072
• 发表时间: 2014-06-24
• 期刊: JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
• 影响因子: 24
• 作者: Patton, Kristen K.;Hellkamp, Anne S.;Lee, Kerry L.;Mark, Daniel B.;Johnson, George W.;Anderson, Jill;Bardy, Gust H.;Poole, Jeanne E.
• 通讯作者: Poole, Jeanne E.