In:
Heart, BMJ, Vol. 108, No. 24 ( 2022-12), p. 1979-1985
Abstract:
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 I nt r avenous ir on treat m ent versus standard care in p a tie n ts 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. Trial registration number NCT02642562 .
Type of Medium:
Online Resource
ISSN:
1355-6037
,
1468-201X
DOI:
10.1136/heartjnl-2022-321304
Language:
English
Publisher:
BMJ
Publication Date:
2022
detail.hit.zdb_id:
1303417-0
detail.hit.zdb_id:
1475501-4
