Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 730
- 试验地点
- 19
- 主要终点
- Overall survival
研究概览
简要总结
The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.
详细描述
Rationale Although not recognized by guidelines, there is no available data demonstrating the benefit of Implantable Cardioverter Defibrillator (ICD) for primary prevention strategy of Sudden Cardiac Death (SCD) in elderly. Nevertheless, ICD are currently implanted in this population by extending the results obtained in randomized trials involving younger subjects to the elderly. Finally, if the absence of implantation in the elderly was not inferior to the implantation of such a device, the non-implantation would avoid the device-related complications and decrease the health costs.
Main objective The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.
Design This is a 2-arm parallel non-inferiority, randomized, open label, multicenter trial. 730 patients will be included over 4 years. Follow up will last 4 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Three experts in cardiac electrophysiology and ICD will be in charge of uniformly approving, while blinded to the study group, ICD tracings, cardiovascular events, including specific causes of death, in order to validate the primary and secondary endpoints.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥70 years old,
- •Left ventricular ejection fraction ≤ 35%, assessed by echocardiography, single-photon emission computed tomography and radionuclide ventriculography and/or cardiac magnetic resonance (CMR) (assessed at inclusion or within the 6 weeks prior to inclusion).
- •NYHA class II or III
- •Heart failure HFOT ≥ 3 months (Possible exceptions : possibility of including patients who do not tolerate the maximum dose or who do not tolerate all four therapeutic classes, as well as the possibility of not waiting for three months when one of the classes is discontinued or when dosage adjustments are made due to poor tolerance ...)
- •Providing informed consent
- •Affiliated to a French Health Insurance system.
排除标准
- •Enrolled in or planning to enroll in a conflicting interventional trial (trial evaluating the interest of ICD or modifying HFOT outside the last ESC Guidelines)
- •Prior unstable sustained ventricular arrhythmia requiring external cardioversion
- •Myocardial infarction within the 40 days
- •Coronary artery intervention (catheter or surgical) within 90 days
- •History of syncope in the previous 6 months
- •Advanced cerebrovascular disease (cerebrovascular disease with functional repercussions or effect on the patient's autonomy)
- •Cognitive impairment leading to the incapacity of consent
- •Any disease other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.
- •Patient under tutorship, curatorship, or legal safeguard
- •Persons deprived of their liberty by judicial or administrative decision (prisoner)
结局指标
主要结局
Overall survival
时间窗: 48 months after randomization
The primary endpoint will be the overall survival at 48 months after randomization to "HFOT alone" group or "HFOT+ICD" group. There is an annual follow-up with precise date of the fatal event and specific cause of death adjudicated by the blinded event committee.
次要结局
- Cardiovascular mortality(48 months after randomization)
- Sudden cardiac death and death from ventricular arrhythmias(48 months after randomization)
- Unplanned hospitalization due to cardiovascular causes(48 months after randomization)
- ICD related complications including inappropriate therapies(48 months after randomization)
- Global quality of life score with 36-Item Short Form Survey (SF36)(baseline, 6, 12, 24, 36 and 48 months)
- Health-related quality of life score Euroqol EQ-5D questionnaire(baseline, 6, 12, 24, 36 and 48 months)
- Patient's global self-assessment of heart failure-related quality of life score(baseline, 6, 12, 24, 36 and 48 months)
- The Incremental cost-utility ratio. (ICUR)(48 months)
- The incremental cost-effectiveness ratio (ICER)(48 months)