Rationale and design of a randomized clinical trial to assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy: The Frequent Optimization Study Using the QuickOpt Method (FREEDOM) trial
Rationale and design of a randomized clinical trial to assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy: The Frequent Optimization Study Using the QuickOpt Method (FREEDOM) trial
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DOI：
10.1016/j.ahj.2010.02.034
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发表时间：
2010-06-01
影响因子：
4.8
通讯作者：
Gupta, Manish S.
中科院分区：
文献类型：
--
作者：
Abraham, William T.;Gras, Daniel;Gupta, Manish S.
目的 本研究的目的是描述一项随机、双盲、对照试验的基本原理、设计和终点，该试验评估接受心脏再同步治疗 (CRT) 的患者房室 (AV) 和心室间 (VV) 延迟的频繁系统优化。 方法 在 16 个国家的 178 个地点招募了 1580 名具有 CRT 标准临床指征的心力衰竭患者。在植入能够使用基于设备的新算法进行 AV 和 VV 优化的 CRT 系统后 2 周内，患者被随机分配到频繁优化组与经验设备编程或任何其他非基于设备的 CRT 优化方法（标准护理组）。在频繁优化组的患者中，每 3 个月计算、重新评估 AV 和 VV 延迟，并在必要时重新编程。在标准护理组的患者中，设备编程由植入医生自行决定，并且在整个试验过程中保持不变，除非临床状态发生变化要求。该试验的主要终点是心力衰竭临床综合指标，根据预先设定的定义将患者分为恶化、无变化或改善。次要终点包括因心血管原因住院和全因死亡率。终点由对研究分配不知情的独立委员会裁定。 结论 FREEDOM 试验预计将于 2009 年末结束，该试验将确定使用基于设备的新算法频繁优化 CRT 是否与比当前护理标准更好的临床结果相关。除了改善患者护理之外，这种方法还可以减轻当前 CRT 设备优化方法带来的工作量和经济负担。 （Am Heart J 2010；159：944-948.e1。）
Objective The aim of the study was to describe the rationale, design, and end points of a randomized, double-blind, controlled trial evaluating frequent systematic optimization of atrioventricular (AV) and interventricular (VV) delays in patients receiving cardiac resynchronization therapy (CRT).Methods One thousand five hundred eighty heart failure patients, with standard clinical indications for CRT, were enrolled at 178 sites in 16 countries. Within 2 weeks after implantation of a CRT system capable of using a new device-based algorithm for AV and VV optimization, patients were randomly assigned to frequent optimization arm versus empiric device programming or any other non-device-based method of CRT optimization (standard of care arm). In patients in the frequent optimization arm, the AV and VV delays were calculated, reevaluated, and, if necessary, reprogrammed every 3 months. In patients in the standard of care arm, device programming was left to the implanting physician's discretion and remained unchanged throughout the trial unless mandated by a change in clinical status. The primary end point of the trial is the heart failure clinical composite, which classifies patients as worsened, unchanged, or improved based on prespecified definitions. Secondary end points include hospitalizations for cardiovascular reasons and all-cause mortality. End points are adjudicated by an independent committee blinded to study assignment.Conclusions The FREEDOM trial, expected to conclude late in 2009, will determine whether frequent optimization of CRT, using a new device-based algorithm, is associated with better clinical outcomes than current standard of care. In addition to improving patient care, this approach might alleviate the workload and economic burden imposed by current approaches to optimization of CRT devices. (Am Heart J 2010; 159: 944-948.e1.)