Rationale and design of the AFFIRM-AHF trial: a randomised, double-blind, placebo-controlled trial comparing the effect of intravenous ferric carboxymaltose on hospitalisations and mortality in iron-deficient patients admitted for acute heart failure
Rationale and design of the AFFIRM-AHF trial: a randomised, double-blind, placebo-controlled trial comparing the effect of intravenous ferric carboxymaltose on hospitalisations and mortality in iron-deficient patients admitted for acute heart failure
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DOI：
10.1002/ejhf.1710
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发表时间：
2019-12-28
影响因子：
18.2
通讯作者：
Jankowska, Ewa A.
中科院分区：
文献类型：
--
作者：
Ponikowski, Piotr;Kirwan, Bridget-Anne;Jankowska, Ewa A.
目的 缺铁 (ID) 是心力衰竭 (HF) 的常见并发症，与功能能力受损、生活质量差以及发病率和死亡率增加相关。静脉注射 (i.v.) 羧基麦芽糖铁 (FCM) 治疗可改善射血分数降低的稳定型心力衰竭患者的功能、症状和生活质量。静脉注射的效果补充铁剂对因急性心力衰竭 (AHF) 住院且患有智力障碍的患者的发病率和死亡率的影响尚未确定。本文的目的是介绍 AFFIRM-AHF 试验 (NCT02937454) 的基本原理和设计，该试验将研究静脉注射的效果。 FCM（与安慰剂相比）对因 AHF 住院的缺铁患者的复发性 HF 住院和心血管 (CV) 死亡率的影响。方法 AFFIRM-AHF 是一项多中心、随机 (1:1)、双盲、安慰剂对照试验，招募了 1100 名因 AHF 住院且缺铁 ID 定义为血清铁蛋白的患者
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 ( 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