Rationale and design of Ferinject assessment in patients with IRon deficiency and chronic Heart Failure (FAIR-HF) study: a randomized, placebo-controlled study of intravenous iron supplementation in patients with and without anaemia.
Rationale and design of Ferinject assessment in patients with IRon deficiency and chronic Heart Failure (FAIR-HF) study: a randomized, placebo-controlled study of intravenous iron supplementation in patients with and without anaemia.
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DOI：
10.1093/eurjhf/hfp140
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发表时间：
2009-11
影响因子：
18.2
通讯作者：
FAIR-HF committees and investigators
中科院分区：
文献类型：
--
作者：
Anker SD;Colet JC;Filippatos G;Willenheimer R;Dickstein K;Drexler H;Lüscher TF;Mori C;von Eisenhart Rothe B;Pocock S;Poole-Wilson PA;Ponikowski P;FAIR-HF committees and investigators
慢性心力衰竭(CHF)患者普遍存在缺铁(ID)和贫血。贫血的存在与CHF发病率和死亡率的增加有关，而ID是贫血发展的主要原因。静脉注射的初步研究在CHF和ID患者中单独补充铁已经显示出症状状态的改善。FIRE-HF(临床试验.gov NCT00520780)用于确定静脉注射的效果。这是一项多中心、随机、双盲、安慰剂对照的研究，招募了有症状的充血性心力衰竭患者，其左心室射血分数≤为40%(纽约心脏协会II级)或≤45%(纽约心脏协会三级)，ID[铁蛋白100 ng/mL或转铁蛋白饱和时铁蛋白100-300 ng/mL]，血红蛋白9.5-13.5g/dL。患者按2：1的比例随机接受Carboxymaltose(Ferinject®)200 mg铁静脉注射。或生理盐水静脉注射。每周一次，直到铁补充(修正阶段)，然后每月，直到第24周(维护阶段)。主要终点是(I)第24周自我报告的PGA和(Ii)第24周的NYHA分级，根据基线NYHA分级进行调整。本研究将为伴和不伴贫血的充血性心力衰竭患者应用羧甲基麦芽糖铁补充铁的有效性和安全性提供证据。
Iron deficiency (ID) and anaemia are common in patients with chronic heart failure (CHF). The presence of anaemia is associated with increased morbidity and mortality in CHF, and ID is a major reason for the development of anaemia. Preliminary studies using intravenous (i.v.) iron supplementation alone in patients with CHF and ID have shown improvements in symptom status. FAIR-HF (Clinical Trials.gov NCT00520780) was designed to determine the effect of i.v. iron repletion therapy using ferric carboxymaltose on self-reported patient global assessment (PGA) and New York Heart Association (NYHA) in patients with CHF and ID. This is a multi-centre, randomized, double-blind, placebo-controlled study recruiting ambulatory patients with symptomatic CHF with LVEF ≤ 40% (NYHA II) or ≤45% (NYHA III), ID [ferritin <100 ng/mL or ferritin 100–300 ng/mL when transferrin saturation (TSAT) < 20%], and haemoglobin 9.5–13.5 g/dL. Patients were randomized in a 2:1 ratio to receive ferric carboxymaltose (Ferinject®) 200 mg iron i.v. or saline i.v. weekly until iron repletion (correction phase), then monthly until Week 24 (maintenance phase). Primary endpoints are (i) self-reported PGA at Week 24 and (ii) NYHA class at Week 24, adjusted for baseline NYHA class. This study will provide evidence on the efficacy and safety of iron repletion with ferric carboxymaltose in CHF patients with ID with and without anaemia.
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影响因子：
4.2
作者：
Haas, JD;Brownlie, T
通讯作者：
Brownlie, T
DOI：
10.1111/j.2517-6161.1995.tb02031.x
发表时间：
1995-01-01
影响因子：
5.8
作者：
BENJAMINI, Y;HOCHBERG, Y
通讯作者：
HOCHBERG, Y
影响因子：
37.8
作者：
Mancini, DM;Katz, SD;Androne, AS
通讯作者：
Androne, AS
影响因子：
24
作者：
Okonko, Darlington O.;Grzeslo, Agnieszka;Ponikowski, Piotr
通讯作者：
Ponikowski, Piotr
影响因子：
39.3
作者：
Komajda, Michel;Anker, Stefan D.;Poole-Wilson, Philip A.
通讯作者：
Poole-Wilson, Philip A.