摘要

AIMS:The aim of this study was to determine whether intermittent ambulatory treatment with levosimendan would improve functional capacity, quality of life, and event-free survival in patients with advanced heart failure.
METHODS AND RESULTS:This was a prospective, randomized, double-blind, placebo-controlled, multicentre, parallel-group trial of pulsed infusions of levosimendan in 120 outpatients with advanced heart failure (EF ≤35%, NYHA class III or IV). The study was conducted at 11 centres in Austria, Greece, and Germany. Levosimendan (0.2 µg/kg/min) or placebo was administered for 6 h at 2-week intervals over 6 weeks, in addition to standard care therapy. The primary outcome was the proportion of patients with a ≥20% improvement in the 6 min walk test and a ≥15% score increase on the Kansas City Cardiomyopathy Questionnaire at the end of the 24-week study period. Secondary outcomes included event-free survival after 24 weeks. Analyses were performed on an intention-to-treat basis. The primary endpoint was reached in 19% of patients receiving levosimendan and 15.8% of patients receiving placebo (odds ratio 1.25; 95% confidence interval 0.44-3.59; P = 0.810). Cardiac death (four vs. one), heart transplants (two vs. one), and acute heart failure (14 vs. nine) were more frequent with placebo as compared with levosimendan. The incidence of side effects was comparable between groups.
CONCLUSION:Intermittent ambulatory treatment with levosimendan in patients with advanced heart failure did not improve significantly functional capacity or quality of life as compared with placebo. An adequately powered, event-driven trial is warranted to enlarge on our findings.
TRIAL REGISTRATION:NCT01065194.

译文

目的: 本研究的目的是确定左西孟旦间歇非卧床治疗是否能改善晚期心力衰竭患者的功能能力、生活质量和无事件生存。
方法和结果: 这是一个前瞻性、随机、双盲、安慰剂对照、多中心、在 120 名门诊晚期心力衰竭患者 (EF ≤ 35%，NYHA III 级或 IV 级) 中进行左西孟旦脉冲输注的平行组试验。这项研究在奥地利、希腊和德国的 11 个中心进行。除了标准护理疗法外，还每隔 2 周服用左西孟旦 (0.2 μ g/kg/min) 或安慰剂 6 小时。主要结果是在 24 周研究结束时，6 分钟步行测试改善 ≥ 20%，堪萨斯城心肌病问卷评分增加 ≥ 15% 的患者比例。周期。次要结果包括 24 周后的无事件生存。分析是在意向治疗的基础上进行的。19% 接受左西孟旦的患者和 15.8% 接受安慰剂的患者达到了主要终点 (比值比 1.25; 95% 置信区间 0.44-3.59; P = 0.810)。与左西孟旦相比，安慰剂组心源性死亡 (4 例对 1 例) 、心脏移植 (2 例对 1 例) 和急性心力衰竭 (14 例对 9 例) 更为频繁。两组之间的副作用发生率具有可比性。
结论: 与安慰剂相比，在晚期心力衰竭患者中使用左西孟旦间歇行走治疗并没有显著改善功能能力或生活质量。一个充分动力的、事件驱动的试验需要扩大我们的发现。
试用注册: nct01065194。