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首页> 外文期刊>ESC Heart Failure >Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post‐discharge period
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Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post‐discharge period

机译：易出院后晚期慢性心力衰竭患者反复左西孟旦输注

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Hospitalization for acute heart failure (HF) is associated with a substantial morbidity burden and with associated healthcare costs and an increased mortality risk. However, few if any major medical innovations have been witnessed in this area in recent times. Levosimendan is a first‐in‐class calcium sensitizer and potassium channel opener indicated for the management of acute HF. Experience in several clinical studies has indicated that administration of intravenous levosimendan in intermittent cycles may reduce hospitalization and mortality rates in patients with advanced HF; however, none of those trials were designed or powered to give conclusive insights into that possibility. This paper describes the rationale and protocol of LeoDOR (levosimendan infusions for patients with advanced chronic heart failure), a randomized, double‐blind, placebo‐controlled, international, multicentre trial that will explore the efficacy and safety of intermittent levosimendan therapy, in addition to optimized standard therapy, in patients following hospitalization for acute HF. Salient features of LeoDOR include the use of two treatment regimens, in order to evaluate the effects of different schedules and doses of levosimendan during a 12?week treatment phase, and the use of a global rank primary endpoint, in which all patients are ranked across three hierarchical groups ranging from time to death or urgent heart transplantation or implantation of a ventricular assist device to time to rehospitalization and, lastly, time‐averaged proportional change in N‐terminal pro‐brain natriuretic peptide. Secondary endpoints include changes in HF symptoms and functional status at 14?weeks.
机译：急性心力衰竭（HF）的住院与大量的发病负担，相关的医疗费用和增加的死亡风险相关。但是，最近很少有人在这一领域看到重大的医学创新。左西孟旦是一流的钙敏化剂和钾通道开放剂，适用于急性HF的管理。几项临床研究的经验表明，间歇性给予静脉注射左西孟旦可以降低晚期心衰患者的住院率和死亡率。但是，这些试验都没有设计或提供任何有力的见解来证明这种可能性。本文介绍了LeoDOR（用于晚期慢性心力衰竭患者的左西孟旦输液）的原理和方案，这是一项随机，双盲，安慰剂对照的国际多中心试验，旨在探讨间歇性左西孟旦治疗的有效性和安全性。急性心衰住院治疗的患者中，优化标准治疗方案。 LeoDOR的主要特征包括使用两种治疗方案，以评估12周治疗阶段左西孟旦的不同时间表和剂量所产生的影响，以及使用全局排名主要终点，即所有患者均按不同等级进行排名分为三个等级，从死亡到死亡，紧急心脏移植，心室辅助设备的植入，再到住院治疗的时间，最后是N末端前脑利钠肽的时间平均比例变化。次要终点包括14周时心衰症状和功能状态的变化。

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