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首页> 外文期刊>ESC Heart Failure >Single‐dose intravenous iron in Southeast Asian heart failure patients: A pilot randomized placebo‐controlled study (PRACTICE‐ASIA‐HF)
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Single‐dose intravenous iron in Southeast Asian heart failure patients: A pilot randomized placebo‐controlled study (PRACTICE‐ASIA‐HF)

机译：东南亚心力衰竭患者的单剂量静脉铁剂：一项随机安慰剂对照研究（PRACTICE-ASIA-HF）

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Aims Iron deficiency is highly prevalent in Southeast Asians with heart failure (HF) and associated with worse outcomes. This trial aimed to assess the effect of intravenous iron in Southeast Asians hospitalized with decompensated HF. Methods and results Fifty patients hospitalized for acute decompensated HF, regardless of ejection fraction, with iron deficiency (defined as serum ferritin 300?ng/mL if transferrin saturation is 20%) were randomized to receive either one dose of intravenous ferric carboxymaltose (FCM) 1000?mg or placebo (0.9% saline) following HF stabilization and before discharge in two Singapore tertiary centres. The primary endpoint was difference in 6‐min walk test (6MWT) distance over 12?weeks, while secondary endpoints were quality of life assessed using validated Kansas City Cardiomyopathy Questionnaire (KCCQ) and Visual Analogue Scale (VAS). Improvement in 6MWT distance at Week 12 was observed in both FCM and placebo groups (from 252?±?123 to 334?±?128?m and from 243?±?67 to 301?±?83?m, respectively). Unadjusted analysis showed 6MWT distance for FCM exceeded that for placebo, but adjustment for baseline covariates and time attenuated this effect {adjusted mean difference between groups: 0.88?m [95% confidence interval (CI) ?30.2 to 32.0, P ?=?0.956]}. KCCQ overall summary and VAS were similar in both groups [adjusted mean difference: KCCQ ?1.48 (95% CI ?8.27 to 5.31, P ?=?0.670) and VAS 0.26 (95% CI ?0.33 to 0.86, P ?=?0.386)]. FCM was well tolerated with no serious treatment‐related adverse events. Conclusions Intravenous FCM administered pre‐discharge in Southeast Asians hospitalized with decompensated HF is clinically feasible. Changes in 6MWT distance should be measured beyond Week 12 to account for background therapy effects.
机译：目的缺铁在患有心力衰竭（HF）的东南亚人中非常普遍，并伴有更坏的结果。该试验旨在评估在静脉代偿性HF住院的东南亚人中静脉注射铁剂的效果。方法和结果将50例住院的急性失代偿性HF患者，无论其射血分数如何，均伴有铁缺乏症（定义为血清铁蛋白<300？ng / mL，如果转铁蛋白饱和度<20％），则随机接受一剂静脉注射羧甲基麦芽糖铁（ FCM）HF稳定后并在两个新加坡三级中心出院前1000 mg或安慰剂（0.9％盐水）。主要终点是在12周内进行6分钟步行测试（6MWT）的距离差异，而次要终点是使用经过验证的堪萨斯城心肌病问卷（KCCQ）和视觉模拟量表（VAS）评估的生活质量。在FCM组和安慰剂组中，第12周的6MWT距离均有改善（分别从252？±？123至334？±？128？m和从243？±？67至301？±？83？m）。未经调整的分析表明，FCM的6MWT距离超过了安慰剂，但基线协变量和时间的调整减弱了这一影响{两组之间的调整后平均差异：0.88？m [95％置信区间（CI）为30.2至32.0，P == 0.956 ]}。两组的KCCQ总体总结和VAS相似[调整后的均值差异：KCCQ = 1.48（95％CI = 8.27至5.31，P = 0.670）和VAS 0.26（95％CI = 0.33至0.86，P = 0.386）。 ）]。 FCM耐受性良好，无严重的治疗相关不良事件。结论在东南亚地区，使用失代偿性HF住院的流式FCM预先出院在临床上是可行的。在第12周后应测量6MWT距离的变化，以说明背景治疗的影响。

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