羧基麦芽糖铁对缺铁性慢性心力衰竭患者发病率和死亡率的评估（FAIR-HF2-DZHK05）试验：基线特征及与其他相关临床试验的比较

Ferric carboxymaltose assessment of morbidity and mortality in patients with iron deficiency and chronic heart failure (FAIR-HF2-DZHK05) trial: Baseline characteristics and comparison to other relevant clinical trials.

作者信息

Anker Stefan D, Friede Tim, Butler Javed, Talha Khawaja M, Placzek Marius, Diek Monika, Nosko Anna, Stas Adriane, Kluge Stefan, Jarczak Dominik, Deheer Geraldine, Rybczynski Meike, Bayes-Genis Antoni, Edelmann Frank, Filippatos Gerasimos, Hasenfuß Gerd, Haverkamp Wilhelm, Lainscak Mitja, Landmesser Ulf, Macdougall Iain C, Merkely Bela, Pieske Burkert M, Pinto Fausto J, Rassaf Tienush, Volterrani Maurizio, von Haehling Stephan, Anker Markus S, Doehner Wolfram, Ince Hüseyin, Koehler Friedrich, Savarese Gianluigi, Rauch-Kröhnert Ursula, Gori Tommaso, Trenkwalder Teresa, Akin Ibrahim, Paitazoglou Christina, Kobielusz-Gembala Iwona, Zmuda Witold, Kuthi Luca, Frey Norbert, Licka Manuela, Kääb Stefan, Laugwitz Karl-Ludwig, Ponikowski Piotr, Karakas Mahir

机构信息

Deutsches Herzzentrum der Charité, Campus Virchow Klinikum, Berlin, Germany.

Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.

出版信息

Eur J Heart Fail. 2025 Apr 29. doi: 10.1002/ejhf.3658.

DOI:10.1002/ejhf.3658

PMID:40300786

Abstract

AIMS

Prior randomized trials have reported conflicting evidence regarding the efficacy of intravenous (IV) iron in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency (ID).

METHODS AND RESULTS

FAIR-HF2 is a double-blind, randomized, controlled trial evaluating the efficacy of IV ferric carboxymaltose in patients with HFrEF and ID. We report the baseline characteristics of enrolled patients and compare them with other major trials of IV iron in HFrEF (FAIR-HF, CONFIRM-HF, AFFIRM-AHF, IRONMAN, and HEART-FID). A total of 1105 patients were randomized between March 2017 and November 2023. Most patients were men (67%) and median age was 72 (interquartile range [IQR] 63-79) years. More than one-third had a heart failure hospitalization within the preceding 12 months (36%), and 53% were hospitalized at randomization. Common comorbidities included hypertension (79%), coronary artery disease (74%), dyslipidaemia (67%), and diabetes (46%). The median left ventricular ejection fraction was 58% (IQR 42-77) and mean estimated glomerular filtration rate was 58 (IQR 42-77) ml/min/1.73 m. A total of 1064 (96%) patients were on renin-angiotensin system inhibitors (angiotensin receptor-neprilysin inhibitors [ARNI] 38%), 1016 (92%) on beta-blockers, and 779 (71%) on mineralocorticoid receptor antagonists; and 261 (24%) of patients were on sodium-glucose cotransporter 2 (SGLT2) inhibitors, which is much higher than prior trials. A higher proportion of patients had ischaemic HFrEF (78%) compared to preceding trials. The baseline median haemoglobin (g/dl) was 12.7 (IQR 11.8-13.4), median serum ferritin (μg/dl) was 63 (IQR 36-90), and median transferrin saturation (%) was 16.5 (IQR 11.8-22.9), resembling that of other trials. The mean 6-min walk distance at enrolment was 314 ± 118 m.

CONCLUSION

The FAIR-HF2 trial represents a contemporary cohort of patients with baseline characteristics mostly similar to prior trial populations. Use of SGLT2 inhibitors and ARNI in FAIR-HF2 was higher than in prior trials.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov ID NCT03036462.

摘要

目的

先前的随机试验报告了关于静脉注射铁剂对射血分数降低的心力衰竭（HFrEF）和缺铁（ID）患者疗效的相互矛盾的证据。

方法和结果

FAIR-HF2是一项双盲、随机、对照试验，评估静脉注射羧麦芽糖铁对HFrEF和ID患者的疗效。我们报告了入组患者的基线特征，并将其与HFrEF中其他主要静脉注射铁剂试验（FAIR-HF、CONFIRM-HF、AFFIRM-AHF、IRONMAN和HEART-FID）进行比较。2017年3月至2023年11月期间，共有1105例患者被随机分组。大多数患者为男性（67%），中位年龄为72岁（四分位间距[IQR]63 - 79岁）。超过三分之一的患者在过去12个月内有过心力衰竭住院史（36%），53%的患者在随机分组时住院。常见合并症包括高血压（79%）、冠状动脉疾病（74%）、血脂异常（67%）和糖尿病（46%）。左心室射血分数中位数为58%（IQR 42 - 77），平均估计肾小球滤过率为58（IQR 42 - 77）ml/min/1.73m²。共有1064例（96%）患者使用肾素 - 血管紧张素系统抑制剂（血管紧张素受体 - 脑啡肽酶抑制剂[ARNI]占38%），1016例（92%）使用β受体阻滞剂，779例（71%）使用盐皮质激素受体拮抗剂；261例（24%）患者使用钠 - 葡萄糖协同转运蛋白2（SGLT2）抑制剂，这一比例高于先前试验。与先前试验相比，缺血性HFrEF患者比例更高（78%）。基线血红蛋白中位数（g/dl）为12.7（IQR 11.8 - 13.4），血清铁蛋白中位数（μg/dl）为63（IQR 36 - 90），转铁蛋白饱和度中位数（%）为16.5（IQR 11.8 - 22.9），与其他试验相似。入组时平均6分钟步行距离为314±118米。