IRONMAN
Trial question
What is the role of intravenous ferric derisomaltose in patients with HFrEF and iron deficiency?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
26.0% female
74.0% male
N = 1137
1137 patients (300 female, 837 male).
Inclusion criteria: adult patients with HFrEF and iron deficiency.
Key exclusion criteria: serum ferritin concentration > 400 mcg/L; hemoglobin concentration < 9 g/dL; men with hemoglobin concentration > 14 g/dL and women with hemoglobin concentration > 13 g/dL.
Interventions
N=569 ferric derisomaltose (intravenous dose of 20 mg/kg up to a maximum of 2,000 mg based on the body weight).
N=568 usual care (standard care).
Primary outcome
Incidence of recurrent hospital admissions for heart failure and CV death
22.4
27.5
27.5/100 py
20.6/100 py
13.8/100 py
6.9/100 py
0.0/100 py
Ferric
derisomaltose
Usual
care
No significant
difference ↔
No significant difference in the incidence of recurrent hospital admissions for HF and CV death (22.4/100 py vs. 27.5/100 py; RR 0.82, 95% CI 0.66 to 1.02).
Secondary outcomes
No significant difference in the incidence of hospital admissions for HF (16.7/100 py vs. 20.9/100 py; RR 0.8, 95% CI 0.62 to 1.03).
No significant difference in cardiovascular hospital admission (45% vs. 48%; HR 0.9, 95% CI 0.76 to 1.07).
No significant difference in CV death or hospital admission for HF (35% vs. 41%; HR 0.84, 95% CI 0.7 to 1.02).
Safety outcomes
No significant differences in system organ serious adverse events, death and hospitalizations due to infection.
Significant difference in cardiac serious adverse events (36% vs. 43%).
Conclusion
In adult patients with HFrEF and iron deficiency, ferric derisomaltose was not superior to usual care with respect to the incidence of recurrent hospital admissions for HF and CV death.
Reference
Paul R Kalra, John G F Cleland, Mark C Petrie et al. 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.
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