Adjudication of Hospitalizations and Deaths in the IRONMAN Trial of Intravenous Iron for Heart Failure

IRONMAN Study Group, John G.F. Cleland (Lead / Corresponding author), Pierpaolo Pellicori, Fraser J. Graham, Rebecca Lane, Mark C. Petrie, Fozia Ahmed, Iain B. Squire, Andrew Ludman, Alan Japp, Abdallah Al-Mohammad, Andrew L. Clark, Ben Szwejkowski, Chris Critoph, Victor Chong, Rebekah Schiff, Thuraia Nageh, Jason Glover, John J.V. McMurray, Elizabeth A. ThomsonMichele Robertson, Ian Ford, Philip A. Kalra, Paul R. Kalra

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)
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Abstract

Background 

Patients with heart failure and iron deficiency have diverse causes for hospitalization and death that might be affected by iron repletion. 

Objectives 

The purpose of this study was to explore causes of hospitalizations and deaths in a randomized trial (IRONMAN) of heart failure comparing intravenous ferric derisomaltose (FDI) (n = 568) and usual care (n = 569). 

Methods 

Patients with heart failure, left ventricular ejection fraction ≤45%, and either transferrin saturation <20% or serum ferritin <100 μg/L were enrolled. Median follow-up was 2.7 years (Q1-Q3: 1.8-3.6 years). A committee adjudicated the main and contributory causes of unplanned hospitalizations and deaths. RRs (rate ratios) for selected recurrent events with 95% CIs are also reported. 

Results 

Compared with usual care, patients randomized to FDI had fewer unplanned hospitalizations (RR: 0.83; 95% CI: 0.71-0.97; P = 0.02), with similar reductions in cardiovascular (RR: 0.83; 95% CI: 0.69-1.01) and noncardiovascular (RR: 0.83; 95% CI: 0.67-1.03) hospitalizations, as well as hospitalizations for heart failure (RR: 0.78; 95% CI: 0.60-1.00), respiratory disease (RR: 0.70; 95% CI: 0.53-0.97), or infection (RR: 0.82; 95% CI: 0.66-1.03). Heart failure was the main cause for 26% of hospitalizations and contributed to or complicated a further 12%. Infection caused or contributed to 38% of all hospitalizations, including 27% of heart failure hospitalizations. Patterns of cardiovascular and all-cause mortality were similar for patients assigned to FDI or usual care. 

Conclusions 

In IRONMAN, FDI exerted similar reductions in cardiovascular and noncardiovascular hospitalizations, suggesting that correcting iron deficiency might increase resistance or resilience to a broad range of problems that cause hospitalizations in patients with heart failure.

Original languageEnglish
Pages (from-to)1704-1717
Number of pages14
JournalJournal of the American College of Cardiology
Volume84
Issue number18
Early online date21 Oct 2024
DOIs
Publication statusPublished - 29 Oct 2024

Keywords

  • heart failure
  • hospitalizations
  • intravenous iron
  • iron deficiency
  • randomized trial

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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