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Beneficial effects of ivabradine in patients with heart failure low ejection fraction and heart rate above 77 b.p.m.

机译:伊伐布雷定对心力衰竭低射血分数和心率高于b.p.m.的患者的有益作用

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摘要

Ivabradine has been approved in heart failure with reduced ejection fraction (HFrEF) and elevated heart rate despite guideline‐directed medical therapy (GDMT) to reduce cardiovascular (CV) death and hospitalization for worsening HF. The median value of 77 b.p.m. is the lower bound selected for the regulatory approval in Canada, South Africa, and Australia. Patient‐reported outcomes (PROs) including symptoms, quality of life, and global assessment are considered of major interest in the global plan of care of patients with HF. However, the specific impact of GDMT, and specifically ivabradine, on PRO remains poorly studied. In the subgroup of patients from the Systolic Heart failure treatment with the If inhibitor ivabradine Trial (SHIFT) who had heart rate above the median of 77 b.p.m. (pre‐specified analysis) and for whom the potential for improvement was expected to be larger, we aimed (i) to evaluate the effects of ivabradine on PRO (symptoms, quality of life, and global assessment); (ii) to consolidate the effects of ivabradine on the primary composite endpoint of CV death and hospitalization for HF; and (iii) to reassess the effects of ivabradine on left ventricular (LV) remodelling.
机译:尽管有指导性药物治疗(GDMT)减少心血管(CV)死亡和因HF恶化而住院的治疗,但伊伐布雷定已被批准用于心力衰竭,其射血分数降低(HFrEF)和心率升高。下午77点的中位数是加拿大,南非和澳大利亚为监管批准选择的下限。包括症状,生活质量和总体评估在内的患者报告结局(PRO)被认为是HF患者全球护理计划的主要关注点。但是,GDMT(特别是伊伐布雷定)对PRO的特定影响尚缺乏研究。在使用If抑制剂ivabradine试验(SHIFT)进行的收缩期心力衰竭治疗的患者亚组中,其心率高于中位数77b.p.m。 (预先指定的分析),并且预期改善的潜力更大,我们的目标是(i)评估伊伐布雷定对PRO的影响(症状,生活质量和整体评估); (ii)巩固伊伐布雷定对心血管死亡和心衰住院的主要复合终点的影响; (iii)重新评估伊伐布雷定对左心室重构的影响。

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