Age-stratified effects of intravenous ferric derisomaltose in heart failure with iron deficiency: insights from the IRONMAN trial.
Sze, Shirley Squire, Iain Kalra, Paul R Cleland, John G Petrie, Mark C Kalra, Philip A Ahmed, Fozia Banerjee, Prithwish Boos, Christopher J Chapman, Callum
Sze, Shirley
Squire, Iain
Kalra, Paul R
Cleland, John G
Petrie, Mark C
Kalra, Philip A
Ahmed, Fozia
Banerjee, Prithwish
Boos, Christopher J
Chapman, Callum
Affiliation
Department of Cardiology, University Hospitals Coventry & Warwickshire, Coventry, UK
Other Contributors
Publication date
2025-06-13
Subject
Collections
Research Projects
Organizational Units
Journal Issue
Abstract
BACKGROUND: Intravenous iron therapy with ferric derisomaltose (FDI) has been shown to improve outcomes in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. However, its effects across different age groups remain unclear. This analysis of the Effectiveness of Intravenous Iron Treatment versus Standard Care in Patients with Heart Failure and Iron Deficiency (IRONMAN) trial explored the efficacy and safety of FDI across age groups.
METHODS: The IRONMAN trial was a prospective, open-label, blinded end point randomised controlled trial enrolling patients with HFrEF and iron deficiency. This prespecified analysis stratified the population into four quarters by age group: <67 years, 67-73 years, 74-79 years, >79 years. The primary outcome was a composite of recurrent heart failure hospitalisations and cardiovascular death. Secondary outcomes included changes in haemoglobin and quality of life. Clinical outcomes comparing FDI versus usual care in each age subgroup were analysed by the method of Lin for recurrent events and Cox proportional hazards model for time to first event. Interactions between age and treatment effects were explored.
RESULTS: Among 1137 randomised patients (median age 73 years), the primary outcome rate ratio (FDI vs usual care) was 0.87 (95% CI 0.61 to 1.23) in patients <67 years, 0.93 (95% CI 0.66 to 1.32) in those aged 67-73 years, 0.88 (95% CI 0.59 to 1.33) in those aged 74-79 years and 0.66 (95% CI 0.45 to 0.96) in those aged >79 years (p-interaction=0.38). Improvements in haemoglobin and quality of life scores at 4 months did not differ statistically across age groups (p-interaction=0.92 and 0.64, respectively). Older patients were more symptomatic at baseline, with higher N-terminal-pro B-type natriuretic peptide levels and poorer renal function, but safety outcomes did not differ across age groups.
CONCLUSIONS: We found no evidence that the effects of FDI on heart failure hospitalisations, cardiovascular death, haemoglobin and quality of life differed by age. These findings support its use in patients with HFrEF and iron deficiency, including older adults.
TRIAL REGISTRATION NUMBER: NCT02642562.
Citation
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. PMID: 39938943; PMCID: PMC12229076.
Type
Article