HCA Florida Heart Institute, St. Petersburg, FL, USA.
Hannover Heart Rhythm Center, Hannover Medical School, Hannover, Germany.
Herzschrittmacherther Elektrophysiol. 2023 Mar;34(1):52-58. doi: 10.1007/s00399-022-00920-5. Epub 2023 Jan 25.
According to the current guidelines, implantable cardioverter-defibrillators (ICD) for primary prevention in patients with heart failure and reduced ejection fraction (HFrEF) should not be considered until optimal guideline-directed medical therapy (GDMT) has been achieved for a minimum of 3 months. Optimization of GDMT often needs time beyond 3 months after diagnosis. The aim of the Heart Failure Optimization Study (HF-OPT) is to evaluate the recovery of left ventricular function beyond 3 months after diagnosis of newly diagnosed HFrEF.
The HF-OPT multicenter study is comprised of two non-randomized phases (registry and study). During the first 90 days a wearable cardioverter-defibrillator (WCD) is prescribed and patients are enrolled in an observational pre-study registry. Registry subjects meeting inclusion criteria for the study portion at day 90 have ongoing left ventricular ejection fraction (LVEF) reassessment at 90, 180 and 360 days after the index hospital discharge, regardless of continued WCD use. Approximately 600 subjects will be enrolled in the study portion. Of those, one-third are anticipated to start the study phase at day 90 with reduced LVEF. The primary objective of this study is to observe the rate of recovery of LVEF > 35% between 90 and 180 days, while key secondary endpoints include mortality and WCD recorded arrhythmias and shocks.
The HF-OPT study will provide important information on the rate of additional recovery of LVEF > 35%, between 90 and 180 days, in newly diagnosed HF with reduced LVEF patients being titrated with GDMT. The results of the study may impact indications for primary prophylactic ICD implantation.
根据现行指南，对于射血分数降低的心力衰竭（HFrEF）患者，不应考虑植入式心律转复除颤器（ICD）作为一级预防，除非在诊断后至少 3 个月内实现了最佳指南导向的药物治疗（GDMT）。GDMT 的优化通常需要在诊断后 3 个月以上的时间。心力衰竭优化研究（HF-OPT）的目的是评估新诊断的 HFrEF 诊断后 3 个月后左心室功能的恢复情况。
HF-OPT 多中心研究由两个非随机阶段（注册和研究）组成。在最初的 90 天内，佩戴式除颤器（WCD）被开处，患者被纳入观察性预研究登记。在第 90 天符合研究部分纳入标准的登记受试者在索引出院后 90、180 和 360 天进行持续的左心室射血分数（LVEF）重新评估，无论是否继续使用 WCD。大约 600 名患者将被纳入研究部分。其中，预计三分之一的患者将在第 90 天因 LVEF 降低而开始研究阶段。该研究的主要目的是观察 LVEF 在 90 至 180 天之间恢复至＞35%的比例，而关键次要终点包括死亡率和 WCD 记录的心律失常和电击。
HF-OPT 研究将提供有关在接受 GDMT 滴定的新诊断 LVEF 降低的心力衰竭患者中，LVEF 在 90 至 180 天之间进一步恢复＞35%的比例的重要信息。该研究的结果可能会影响原发性预防性 ICD 植入的适应证。
