Sudden Cardiac Death in Heart Failure Trial 10 year Follow-up (SCD-HeFT 10 yr.)

心力衰竭试验 10 年随访中的心脏性猝死 (SCD-HeFT 10 年)

• 批准号: 7836254
• 负责人: Gust Harry Bardy
• 金额: $ 49.6万
• 依托单位: SEATTLE INSTITUTE FOR CARDIAC RESEARCH
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7836254
• 关键词: Amiodarone; Area; Cardiac; Cessation of life; Clinical Trials; Complication; Congestive Heart Failure; Convulsive therapy; Data; Data Set; Double-Blind Method; Economics; Enrollment; Evaluation; Failure; Functional disorder; Funding Opportunities; Generations; Goals; Grant; Hand; Heart failure; Hospitalization; Implantable Defibrillators; Industry; Institutes; Institution; Investigation; Lead; Life; Medical Records; Minority; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Outcome; Outcome Measure; Outcome Study; Paper; Patients; Peer Review; Placebos; Policies; Population; Principal Investigator; Procedures; Publications; Quality of life; Questionnaires; Research; Research Personnel; Role; Source; Subgroup; Time; United States National Institutes of Health; Upper arm; Vital Status; Woman; Work; base; comparative; comparative effectiveness; cost; effectiveness research; follow-up; human subject; insight; mortality; public health relevance; sudden cardiac death; therapy outcome; trial comparing

DESCRIPTION (provided by investigator): This application responds to NIH Challenge Grant RFA-OD-09-003, under the broad Challenge Area (04) and focuses on Comparative Effectiveness Research in a prior NHLBI sponsored clinical trial (The Sudden Cardiac Death in Heart Failure Trial, SCD-HeFT, UO1s HL55297, HL55496, HL55766). The Specific Challenge Topic is 04-HL-106: Implantable cardioverter defibrillators and cardiac resynchronization therapy in heart failure. No clinical trial that has examined implantable cardioverter defibrillator (ICD) therapy outcome data for longer than a few years. SCD-HeFT, conducted from 1997 to 2003, had the largest number of patients and the longest average follow-up at 45.5 months. This study changed the national reimbursement policy for ICD therapy and remains the reference point for all other ICD evaluations in patients with congestive heart failure from ischemic or non-ischemic systolic dysfunction. More than 26 peer-reviewed publications have resulted from this work, including three NEJM papers, with more being drafted. Despite the duration and quality of SCD-HeFT, the role of ICD therapy in the management of patients with heart failure has been questioned because of four principal concerns: numbers needed to treat to save a life, lead integrity over time, the negative consequences of shock therapy, and the cost of the therapy. At the time of the public presentation of the study outcome at the ACC March 8, 2004, all remaining SCD-HeFT patients (1855 out of 2521 enrolled) were instructed to receive an ICD. Within 3 months of that announcement, only 25 patients in the placebo and amiodarone arms of the trial had availed themselves of free ICD therapy. This is both bad and good. It is bad in that approximately two-thirds of the remaining 1855 patients, those on placebo and amiodarone, were not protected from SCD. On the other hand, for the purposes of examining comparative outcomes, it is good in that it is likely that relatively few of the placebo and amiodarone patients ultimately received ICD therapy. Consequently, the Challenge Grant offers a perfect opportunity for a one- time, long-term follow-up of the remaining 1855 SCD-HeFT patients since our last follow-up of October 31, 2003. The 2-year funding opportunity represents an ideal amount of time and money to obtain human subjects approval at the participating institutions and to track down and question the remaining patients or to access their medical records for a one-time, comprehensive questionnaire regarding key outcome data. Because we had 100 per cent vital status follow-up at the close of the study and 99 per cent data completion on the remaining outcome measures, we believe we can approach this same high quality follow-up. The primary goals of this application are: 1. To compare 10-year mortality data on the remaining 1855 SCD-HeFT patients since the close of follow- up from October 31, 2003 in the 3 arms of the trial (ICD, placebo and amiodarone) to allow the generation of 10-year Kaplan-Meier survival curves based upon an intent-to-treat and an on-treatment analysis. The data on the 666 deaths from the original study will be integrated with the new data. 2. To obtain outcome data in the major subgroups of SCD-HeFT: ischemic versus non-ischemic and NYHA Class II versus Class III heart failure, and in woman and minorities. 3. To obtain 10-year ICD use rates, complication rates, lead failure rates and replacement rates. 4. To validate or refute the observation that amiodarone increases mortality in NYHA Class III patients. 5. To obtain 10-year hospitalization and major procedure data. 6. To obtain 10-year quality of life data. Investigation will be conducted by the same principals involved in the original SCD-HeFT work. Gust Bardy will be the principal investigator, Kerry Lee will oversee the biostatistical aspects of the trial, Dan Mark will oversee the economics and quality of life aspects of the study and Jeanne Poole will oversee the ICD data. The Seattle Institute for Cardiac Research (SICR), will, as before, serve as the coordinating center. PUBLIC HEALTH RELEVANCE: The relevance of this comparative effectiveness research trial builds on the quality, numbers, and duration of follow-up of the largest ICD trial ever undertaken: the NHLBI sponsored Sudden Cardiac Death in Heart Failure Trial that compared ICD therapy to placebo and amiodarone to placebo (double blind). By increasing follow-up to 10-years for the entire SCD-HeFT population, we will provide a unique data set on the long-term mortality and morbidity related to ICD therapy as well as deeper and broader insights into therapy costs and ICD replacement and complication rates from a non-industry source.

描述（调查人员提供）：此申请对NIH挑战授予RFA-OD-09-003响应，在广泛的挑战领域（04）下，并重点介绍了先前的NHLBI发起的临床试验（心力衰竭突然心力衰竭试验，SCD-HEFT，SCD-HEFT，UO1S HL555297，HL55297，HL5555496，HL555766，HL55297中的心脏突然心脏死亡试验）。具体的挑战主题是04-HL-106：心力衰竭中的植入式心脏逆转除颤器和心脏重新同步疗法。尚无临床试验，该试验检查了植入式心脏逆变器除颤器（ICD）治疗结果数据超过几年。 SCD-HEFT于1997年至2003年进行，患者人数最多，最长的平均随访时间为45.5个月。这项研究改变了ICD治疗的国家报销政策，仍然是缺血性或非缺血性收缩功能障碍的充血性心力衰竭患者的所有其他ICD评估的参考点。这项工作包括三份NEJM论文，有26多个经过同行评审的出版物。尽管SCD-HEFT的持续时间和质量，但由于四个主要问题，ICD疗法在心力衰竭患者管理中的作用受到了质疑：需要治疗以挽救生命，随着时间的推移，减震疗法的负面后果以及治疗成本的负面影响。在2004年3月8日的ACC公开介绍研究结果时，所有剩余的SCD-HEFT患者（在2521名招募的2521名中）被指示接受ICD。在该公告后的3个月内，该试验中只有25名患者和胺碘酮手臂可以使用免费ICD疗法。这既好又好。这是不好的，因为在安慰剂和胺碘酮上剩下的1855例患者中，大约三分之二没有受到SCD的保护。另一方面，出于检查比较结果的目的，这是很好的，因为相对较少的安慰剂和胺碘酮患者最终最终接受了ICD疗法。因此，自2003年10月31日上次随访以来，挑战赠款为剩余的1855名SCD-HEFT患者提供了一次绝佳的机会。为期2年的资助机会代表了在参与机构中获得人类受试者批准的理想时间和金钱，并访问其剩余的患者并访问其医疗记录或全面的问题，以全面的数据进行访问，以全面的数据访问。由于我们在研究结束时进行了100％的生命状态随访，并在其余结果指标上完成了99％的数据完成，因此我们相信我们可以处理相同的高质量随访。该应用的主要目标是：1。要比较自2003年10月31日从2003年10月31日开始闭幕的剩余1855名SCD-HEFT患者的10年死亡率数据（ICD，安慰剂和amiodarone），以使10年的Kaplan-Meer-Meeier生存曲线的产生基于目的至上和培养分析。原始研究中有关666例死亡的数据将与 新数据。 2。在SCD-HEFT的主要亚组中获取结果数据：缺血性与非缺血性和NYHA II类与III类心力衰竭，以及女性和少数群体中。 3。要获得10年的ICD使用率，并发症率，潜在客户失败率和替换率。 4。验证或反驳观察到的观察结果，即氨二酮会增加NYHA III类患者的死亡率。 5。获得10年的住院和主要程序数据。 6。获得10年的生活质量数据。调查将由最初的SCD-HEFT工作中涉及的相同校长进行调查。 Gust Bardy将担任主要研究员Kerry Lee将监督试验的生物统计学方面，Dan Mark将监督研究的经济学和质量方面，Jeanne Poole将监督ICD数据。西雅图心脏研究研究所（SICR）将与以前一样作为协调中心。 公共卫生相关性：这项比较有效性研究试验的相关性是基于有史以来最大的ICD试验的质量，数量和随访时间：NHLBI在心力衰竭试验中赞助了心脏衰竭试验突然的心脏死亡，将ICD治疗与安慰剂和amiodarone进行了比较。通过将整个SCD-HEFT人群的随访增加到10年，我们将提供有关与ICD疗法有关的长期死亡率和发病率的独特数据，以及对治疗成本以及ICD替代和ICD替代和并发症率的更深入，更广泛的见解。