Effect of Correcting Iron Deficiency on the Risk of Serious Infection in Heart Failure: Insights from the IRONMAN Trial
Year: 2024
Type: article
Abstract: AIMS: Concerns exist that intravenous (IV) iron might increase the risk of infections. The IRONMAN trial provided an opportunity to investigate whether giving IV ferric derisomaltose (FDI) to patients with heart failure and iron deficiency alters the rate of hospitalization or death due to infections. METHODS AND RESULTS: IRONMAN was a randomized trial of IV FDI versus usual care in patients with symptomatic heart failure, left ventricular ejection fraction (LVEF) ≤45%, and transferrin saturation (TSAT) <20% or ferritin <100 μg/L. Infection was a pre-specified, blindly-adjudicated, safety endpoint. The primary analysis of interest was infection as the main reason for hospitalization or death, using first and recurrent events analyses. The composite primary event of interest tended to be lower in those randomized to FDI when analysed as first (hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.62-1.01, p = 0.055) or recurrent event (rate ratio 0.85, 95% CI 0.64-1.13, p = 0.089). The composite results were driven by fewer hospitalizations for infection (HR 0.76, 95% CI 0.49-0.98, p = 0.032), with 5% fewer patients (absolute reduction) experiencing such an event if assigned to FDI. Similar trends were observed for recurrent events (HR 0.82, 95% CI 0.62-1.10). Further analyses suggested that the reduction in hospitalizations due to infection with FDI was restricted to patients with TSAT <20%. CONCLUSIONS: In patients with heart failure and a reduced LVEF, correction of iron deficiency is not associated with an increased risk of hospitalization or death from infection, and may reduce such events, especially when TSAT is <20%. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02642562.
DOI: 10.1002/ejhf.3504
Authors: Paul W. Foley, Paul R. Kalra, John G.F. Cleland, Mark C. Petrie, Philip A. Kalra, Ian Squire, Philip Campbell, Callum Chapman, Patrick Donnelly, Fraser Graham, Andrew Hannah, Ninian N. Lang, Iain Matthews, Stephen J. Leslie, Pierpaolo Pellicori, Sue Piper, Robin Ray, Hernry O. Savage, Chales Spencer, John Walsh, Yuk-Ki Wong, Ian Ford, the IRONMAN Study Group
Institutions: Great Western Hospital, National Health Service, Portsmouth Hospitals NHS Trust, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, University of Portsmouth, University of Glasgow, Glenfield Hospital, NIHR Leicester Biomedical Research Centre, Royal Gwent Hospital, Chelsea and Westminster Hospital, Aberdeen Royal Infirmary, Queen Elizabeth University Hospital, Wansbeck General Hospital, Raigmore Hospital, King's College Hospital, St George's Hospital, Basildon Hospital, New Cross Hospital, Nottingham City Hospital, St Richard's Hospital
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,250
Funder: British Heart Foundation
OpenAlex ID: W4403761618