Department of Cardiology, Portsmouth Hospitals University NHS Trust, Portsmouth, UK.
School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK.
Heart. 2022 Nov 24;108(24):1979-1985. doi: 10.1136/heartjnl-2022-321304.
For patients with a reduced left ventricular ejection fraction (LVEF) heart failure with reduced ejection fraction (HFrEF) and iron deficiency, administration of intravenous iron improves symptoms, exercise capacity and may in the following 12 months, reduce hospitalisations for heart failure. The Effectiveness of ntavenous ir treatent versus standard care in ptiets with heart failure and iron deficiency (IRONMAN) trial evaluated whether the benefits of intravenous iron persist in the longer term and impact on morbidity and mortality.
IRONMAN is a prospective, randomised, open-label, blinded endpoint (PROBE) event-driven trial. Patients aged ≥18 years with HFrEF (LVEF ≤45%) and evidence of iron deficiency (ferritin <100 µg/L and/or TSAT <20%) were enrolled if they had either a current or recent hospitalisation for heart failure or elevated plasma concentrations of a natriuretic peptide. Participants were randomised to receive, or not to receive, intravenous ferric derisomaltose in addition to guideline-recommended therapy for HFrEF. Every 4 months, intravenous iron was administered if either ferritin was <100 µg/L or, provided ferritin was ≤400 µg/L, TSAT was <25%. The primary endpoint is a composite of total hospitalisations for heart failure and cardiovascular death. Hospitalisation and deaths due to infection are safety endpoints.
Trial recruitment was completed across 70 UK hospital sites in October 2021. Participants were followed until the end of March 2022. We plan to report the results by November 2022.
IRONMAN will determine whether repeated doses of intravenous ferric derisomaltose are beneficial and safe for the long-term treatment of a broad range of patients with HFrEF and iron deficiency.
NCT02642562.
对于左心室射血分数（LVEF）降低的心力衰竭伴射血分数降低（HFrEF）和缺铁的患者，静脉补铁可改善症状、运动能力，并且在接下来的 12 个月内，可减少心力衰竭住院治疗。静脉铁治疗与心力衰竭和缺铁患者的标准治疗（IRONMAN）试验评估了静脉铁的益处是否在长期内持续存在，并对发病率和死亡率产生影响。
IRONMAN 是一项前瞻性、随机、开放标签、盲终点（PROBE）事件驱动试验。年龄≥18 岁、射血分数（LVEF）≤45%且存在缺铁证据（铁蛋白<100μg/L 和/或转铁蛋白饱和度<20%）的 HFrEF 患者，如果他们有当前或近期因心力衰竭住院或升高的利钠肽的血浆浓度，符合纳入条件。参与者被随机分配接受或不接受静脉铁剂三价柠檬酸铁多糖复合物，此外还接受 HFrEF 的指南推荐治疗。每 4 个月，如果铁蛋白<100μg/L，或如果铁蛋白≤400μg/L，则转铁蛋白饱和度<25%，则给予静脉铁剂。主要终点是心力衰竭总住院和心血管死亡的复合终点。感染导致的住院和死亡是安全性终点。
试验招募于 2021 年 10 月在英国 70 家医院完成。参与者随访至 2022 年 3 月底。我们计划于 2022 年 11 月报告结果。
IRONMAN 将确定反复给予静脉铁剂三价柠檬酸铁多糖复合物是否对 HFrEF 和缺铁的广泛患者的长期治疗有益且安全。
NCT02642562。
