There are ongoing concerns that administering intravenous (IV) iron could magnify the risk of infections.
In patients with heart failure and diminished LVEF, iron repletion is not linked to an increased incidence of infection-related hospitalizations or deaths and may confer a protective effect, especially in those with TSAT under 20%.
There are ongoing concerns that administering intravenous (IV) iron could magnify the risk of infections. Hence, the IRONMAN trial sought to explore whether treatment with IV ferric derisomaltose in individuals with heart failure and iron deficiency influenced the incidence of infection-related hospitalizations or deaths.
In this randomized controlled trial, patients with symptomatic heart failure, a left ventricular ejection fraction (LVEF) of 45% or below, and either transferrin saturation (TSAT) under 20% or ferritin below 100 μg/L were enrolled. Volunteers were divided to get IV ferric derisomaltose or standard care. Blinded adjudication was used to assess infection, a pre-specified safety endpoint. The main focus was to investigate infections as the primary cause of hospitalization or death, considering both initial and repeated occurrences.
Those receiving ferric derisomaltose exhibited a trend towards fewer infection-related events—both first-time (HR 0.79) and recurrent (rate ratio 0.85). Notably, hospitalizations due to infection were markedly reduced in the ferric derisomaltose group (HR 0.76), with 5% fewer individuals affected. This protective signal was especially evident in those with TSAT below 20%, suggesting that those with more pronounced iron deficiency benefited the most.
For those with heart failure and impaired heart function, addressing iron deficiency doesn’t increase the risk of serious infections—and may actually lower the chance of infection-related hospital stays or deaths, particularly when TSAT falls below 20%. These findings challenge previous concerns and support ferric derisomaltose as a potentially safer strategy in this population.
European Journal of Heart Failure
Effect of correcting iron deficiency on the risk of serious infection in heart failure: Insights from the IRONMAN trial
Paul W Foley et al.
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