Rationale and design of a randomised trial of intravenous iron in patients with heart failure

Kalra, P. R. et al. (2022) Rationale and design of a randomised trial of intravenous iron in patients with heart failure. Heart, 108(24), pp. 1979-1985. (doi: 10.1136/heartjnl-2022-321304) (PMID:35948408) (PMCID:PMC9726969)

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Objectives: 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 Intravenous iron treatment versus standard care in patients 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. Methods: 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. Results: 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. Conclusions: 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.

Item Type:Articles
Additional Information:Funding: IRONMAN is an investigator-initiated trial, designed by members of the TSC (ClinicalTrials.gov identifier: NCT02642562) and funded by the British Heart Foundation (grant award CS/15/1/31175). Pharmacosmos A/S provided and distributed ferric derisomaltose and made an additional contribution to research costs.
Glasgow Author(s) Enlighten ID:Petrie, Professor Mark and Kalra, Professor Paul and Lang, Professor Ninian and Robertson, Mrs Michele and Cleland, Professor John and Thomson, Miss Elizabeth and Pellicori, Dr Pierpaolo and Ford, Professor Ian
Authors: Kalra, P. R., Cleland, J. G. F., Petrie, M. C., Ahmed, F. Z., Foley, P. W. X., Kalra, P. A., Lang, N. N., Lane, R. E., Macdougall, I. C., Pellicori, P., Pope, M. T. B., Robertson, M., Squire, I. B., Thomson, E. A., and Ford, I.
College/School:College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > General Practice and Primary Care
College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre
Journal Name:Heart
Publisher:BMJ Publishing Group
ISSN (Online):1468-201X
Published Online:10 August 2022
Copyright Holders:Copyright © 2022 The Authors
First Published:First published in Heart 108(24): 1979-1985
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
172792Intravenous iron treatment in patients with heart failure and iron deficiency: a multicentre UK study (IRONMAN)Ian FordBritish Heart Foundation (BHF)CS/15/1/31175HW - Robertson Centre
190814BHF centre of excellenceRhian TouyzBritish Heart Foundation (BHF)RE/13/5/30177Institute of Cardiovascular & Medical Sciences
303944BHF Centre of ExcellenceColin BerryBritish Heart Foundation (BHF)RE/18/6/34217CAMS - Cardiovascular Science