AIMS Iron deficiency (ID) is a common co-morbidity in heart failure (HF), associated with impaired functional capacity, poor quality of life and increased morbidity and mortality. Treatment with intravenous (i.v.) ferric carboxymaltose (FCM) has shown improvements in functional capacity, symptoms and quality of life in stable HF patients with reduced ejection fraction. The effect of i.v. iron supplementation on morbidity and mortality in patients hospitalised for acute HF (AHF) and who have ID has yet to be established. The objective of the present article is to present the rationale and design of the AFFIRM-AHF trial (ClinicalTrials.gov NCT02937454) which will investigate the effect of i.v. FCM (vs. placebo) on recurrent HF hospitalisations and cardiovascular (CV) mortality in iron-deficient patients hospitalised for AHF. METHODS AFFIRM-AHF is a multicentre, randomised (1:1), double-blind, placebo-controlled trial which recruited 1100 patients hospitalised for AHF and who had iron deficiency ID defined as serum ferritin <100 ng/mL or 100-299 ng/mL if transferrin saturation <20%. Eligible patients were randomised (1:1) to either i.v. FCM or placebo and received the first dose of study treatment just prior to discharge for the index hospitalisation. Patients will be followed for 52 weeks. The primary outcome is the composite of recurrent HF hospitalisations and CV mortality. The main secondary outcomes include the composite of recurrent CV hospitalisations and CV mortality, recurrent HF hospitalisations and safety-related outcomes. CONCLUSION The AFFIRM-AHF trial will evaluate, compared to placebo, the effect of i.v. FCM on morbidity and mortality in iron-deficient patients hospitalised for AHF.

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AFFIRM-AHF试验的原理和设计：一项随机，双盲，安慰剂对照的试验，比较了静脉注射羧化麦芽糖铁对急性心力衰竭住院铁缺乏症患者的住院率和死亡率的影响。

AIMS铁缺乏症（ID）是心力衰竭（HF）的常见合并症，与功能能力受损，生活质量差以及发病率和死亡率增加有关。静脉内（iv）羧基麦芽糖铁（FCM）的治疗已显示出射血分数降低的稳定HF患者的功能能力，症状和生活质量得到改善。尚无确定静脉补充铁对住院急性心衰（AHF）并有ID的患者发病率和死亡率的影响。本文的目的是介绍AFFIRM-AHF试验（ClinicalTrials.gov NCT02937454）的原理和设计，该试验将研究静脉FCM（相对于安慰剂）对复发性HF住院和铁中心血管（CV）死亡率的影响缺乏AHF住院的患者。方法AFFIRM-AHF是一项多中心，随机（1：1），双盲，安慰剂对照试验，该试验招募了1100例因AHF住院且铁缺乏症ID定义为血清铁蛋白<100 ng / mL或100-299 ng的患者。如果转铁蛋白饱和度<20％，则为/ mL。符合条件的患者被随机分配（1：1）进行静脉FCM或安慰剂治疗，并在出院前就接受了第一剂研究治疗药物，以进行指数住院治疗。患者将被随访52周。主要结果是复发性HF住院和CV死亡率的综合结果。主要的次要结局包括复发性心血管住院和心血管死亡率，复发性心衰住院和安全相关结局的综合。结论与安慰剂相比，AFFIRM-AHF试验将评估静脉输注静脉曲张的疗效。