Effect of ivabradine on left ventricular diastolic function of patients with heart failure with preserved ejection fraction -IVA-PEF study-
Effect of ivabradine on left ventricular diastolic function of patients with heart failure with preserved ejection fraction -IVA-PEF study-
复制标题
伊伐布雷定对射血分数保留的心力衰竭患者左心室舒张功能的影响-IVA-PEF研究-
DOI：
10.1016/j.jjcc.2020.12.012
复制
发表时间：
2021
影响因子：
2.5
通讯作者：
Hirata Ken-ichi
中科院分区：
文献类型：
--
作者：
Tanaka Hidekazu;Yamauchi Yuki;Imanishi Junichi;Hatani Yutaka;Hayashi Takatoshi;Hirata Ken-ichi
背景高静息心率（HR）是心力衰竭（HF）患者心血管结局的已知标志。伊伐布雷定是一种新型的HR降低药物，是窦房结中If电流的特异性抑制剂。在窦性心律下，当将伊伐布雷定添加至基于指南的左心室（LV）射血分数≤35%和HR ≥70 bpm治疗时，可显著降低HF相关的主要风险。另一方面，射血分数正常的HF（HFpEF）目前约占所有HF病例的一半，通常表现为LV舒张功能障碍。然而，HFpEF患者HR降低与LV舒张功能之间的关联仍然不确定。方法/设计本研究探讨IVAbradine对射血分数保留性心力衰竭（IVA-PEF）患者左心室舒张功能的影响，是一项多中心、前瞻性、非对照、开放标签、单次分配，以及一项研究伊伐布雷定对HFpEF患者左室舒张功能影响的干预性单组研究。关键入选标准为窦性心律时静息HR ≥ 75 bpm的HFpEF。在获得完整的知情同意书后，患者将在研究期间接受5 mg/天伊伐布雷定给药。根据二尖瓣流入E和二尖瓣e'环速度（E/e'）评估LV舒张功能。主要终点定义为伊伐布雷定给药开始后3个月E/e′的变化。结论本研究结果为伊伐布雷定治疗HFpEF提供了新的视角。
BackgroundHigh resting heart rate (HR) is a known marker of cardiovascular outcomes for heart failure (HF) patients. Ivabradine is a new class of HR lowering drug and a specific inhibitor of the Ifcurrent in the sinoatrial node. Ivabradine substantially and significantly reduces major risks associated with HF when added to guideline-based treatment for left ventricular (LV) ejection fraction ≤35% and HR ≥70 bpm in sinus rhythm. On the other hand, HF with preserved ejection fraction (HFpEF) currently accounts for roughly half of all HF cases and usually presents as LV diastolic dysfunction. However, the association between HR reduction and LV diastolic function for HFpEF patients remains uncertain.Methods/designThis investigation into the effect of IVAbradine on left ventricular diastolic function of patients with heart failure with Preserved Ejection Fraction (IVA-PEF) is a multicenter, prospective, uncontrolled, open-label, single assignment, and an interventional single-arm study to investigate the effect of ivabradine on LV diastolic function of HFpEF patients. The key inclusion criterion is HFpEF with resting HR ≥75bpm in sinus rhythm. After completed informed consent forms are obtained, patients will be given 5 mg/day of ivabradine during the study. LV diastolic function is assessed in terms of mitral inflow E and mitral e’ annular velocities (E/e’). The primary endpoint will be defined as a change in E/e′ between baseline and 3 months after the start of administration of ivabradine.ConclusionThe findings of our trial may provide a new perspective on ivabradine for the treatment of HFpEF.