drugset / Trial / NCT02642562
Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN
Phase 4
Completed
1160 enrolled
University of Glasgow
British Heart Foundation · collabNHS Greater Glasgow and Clyde · collabPharmacosmos A/S · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This study will address whether the additional use of Intravenous (IV) iron on top of standard care will improve the outlook for patients with heart failure and iron deficiency. One group of participants will receive treatment with iron injections and the other group will not receive any iron injections.
Timeline
- Start
- 2016-08
- Primary completion
- 2022-08-26
- Completion
- 2022-08-26
Publications
- Sze S, Squire I, Kalra PR, Cleland JG, Petrie MC, Kalra PA, Ahmed F, Banerjee P, Boos CJ, Chapman C, Cowburn PJ, Dixon L, Duckett S, Lane R, Foley P, Lang NN, Lyons K, Ray R, Schiff R, Thomson EA, Robertson M, Ford I; IRONMAN Study group. Age-stratified effects of intravenous ferric derisomaltose in heart failure with iron deficiency: insights from the IRONMAN trial. Heart. 2025 Jun 13;111(13):634-641. doi: 10.1136/heartjnl-2024-324908.
- Foley PW, Kalra PR, Cleland JGF, Petrie MC, Kalra PA, Squire I, Campbell P, Chapman C, Donnelly P, Graham F, Hannah A, Lang NN, Matthews I, Leslie SJ, Pellicori P, Piper S, Ray R, Savage HO, Spencer C, Walsh J, Wong YK, Ford I; on behalf of the IRONMAN Study Group. Effect of correcting iron deficiency on the risk of serious infection in heart failure: Insights from the IRONMAN trial. Eur J Heart Fail. 2025 Jan;27(1):166-173. doi: 10.1002/ejhf.3504. Epub 2024 Oct 25.
- Cleland JGF, Pellicori P, Graham FJ, Lane R, Petrie MC, Ahmed F, Squire IB, Ludman A, Japp A, Al-Mohammad A, Clark AL, Szwejkowski B, Critoph C, Chong V, Schiff R, Nageh T, Glover J, McMurray JJV, Thomson EA, Robertson M, Ford I, Kalra PA, Kalra PR; IRONMAN Study Group. Adjudication of Hospitalizations and Deaths in the IRONMAN Trial of Intravenous Iron for Heart Failure. J Am Coll Cardiol. 2024 Oct 29;84(18):1704-1717. doi: 10.1016/j.jacc.2024.08.052.
- Kalra PR, Cleland JGF, Petrie MC, Thomson EA, Kalra PA, Squire IB, Ahmed FZ, Al-Mohammad A, Cowburn PJ, Foley PWX, Graham FJ, Japp AG, Lane RE, Lang NN, Ludman AJ, Macdougall IC, Pellicori P, Ray R, Robertson M, Seed A, Ford I; IRONMAN Study Group. Intravenous ferric derisomaltose in patients with heart failure and iron deficiency in the UK (IRONMAN): an investigator-initiated, prospective, randomised, open-label, blinded-endpoint trial. Lancet. 2022 Dec 17;400(10369):2199-2209. doi: 10.1016/S0140-6736(22)02083-9. Epub 2022 Nov 5.
- Kalra PR, Cleland JG, Petrie MC, Ahmed FZ, Foley PW, Kalra PA, Lang NN, Lane RE, Macdougall IC, Pellicori P, Pope MTB, Robertson M, Squire IB, Thomson EA, Ford I. Rationale and design of a randomised trial of intravenous iron in patients with heart failure. Heart. 2022 Nov 24;108(24):1979-1985. doi: 10.1136/heartjnl-2022-321304.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferric Derisomaltose | Unknown | 20 mg/kg | Intravenous |
| Subject | Ferric Derisomaltose | Unknown | 1000 mg | Intravenous |