Key result
IV ferric derisomaltose consistently reduces recurrent HF hospitalizations and CV death across all age groups.
Why the study?
Intravenous ferric derisomaltose improves outcomes in HFrEF with iron deficiency, but its effects across different age groups remain unclear.
Does intravenous ferric derisomaltose reduce recurrent heart failure hospitalisations and cardiovascular death in patients with HFrEF and iron deficiency across different age groups?
RCT (n=1,137)
Open-label, blinded end point
Does intravenous ferric derisomaltose reduce recurrent heart failure hospitalisations and cardiovascular death in patients with HFrEF and iron deficiency across different age groups?
p-value: p=0.38 (interaction)
Intravenous ferric derisomaltose provides consistent efficacy and safety in reducing heart failure hospitalizations and cardiovascular death in HFrEF patients with iron deficiency, regardless of age.
Supports use irrespective of age in HFrEF with iron deficiency; confirms no age interaction in this RCT.
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 et al 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 .
No takes yet. Share an insight, caveat, or question.
Sze et al. (2025) conducted an RCT in Heart failure with reduced ejection fraction (HFrEF) and iron deficiency (n=1,137). Intravenous ferric derisomaltose vs. Usual care was evaluated on Composite of recurrent heart failure hospitalisations and cardiovascular death (p=0.38 (interaction)). Intravenous ferric derisomaltose reduced recurrent heart failure hospitalizations and cardiovascular death consistently across all age groups (rate ratios 0.66 to 0.93; p-interaction=0.38).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: