Europe PMC

This website requires cookies, and the limited processing of your personal data in order to function. By using the site you are agreeing to this as outlined in our privacy notice and cookie policy.

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.

Show less

Collaborators (170)

Author information

Affiliations

  • 1. Department of Cardiology, Portsmouth Hospitals University NHS Trust, Portsmouth, UK; College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK; Faculty of Science and Health, University of Portsmouth, Portsmouth, UK.
      Authors
    • Kalra PR 1
    (1 author)
  • 2. School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK.
      Authors
    • Cleland JGF 2
    • Petrie MC 2
    • Lang NN 2
    • Pellicori P 2
    (4 authors)
  • 3. Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
      Authors
    • Thomson EA 3
    • Graham FJ 3
    • Robertson M 3
    • Ford I 3
    (4 authors)
  • 4. Department of Renal Medicine, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK; Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.
      Authors
    • Kalra PA 4
    (1 author)
  • 5. Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.
      Authors
    • Squire IB 5
    (1 author)
    • Show all (15)

ORCIDs linked to this article

Show all (12)

Lancet (London, England), 05 Nov 2022, 400(10369):2199-2209
https://doi.org/10.1016/s0140-6736(22)02083-9 PMID: 36347265 

A comment on this article appears in "Intravenous iron passes another endurance test in heart failure." Lancet. 2023 Dec 17;400(10369):2158-2159. A comment on this article appears in "Intravenous ferric derisomaltose for patients with heart failure: does iron heart translate into IRONMAN?" Eur Heart J. 2023 Apr 7;44(14):1203-1204. A comment on this article appears in "In HF with iron deficiency, IV ferric derisomaltose was associated with lower rates of HF hospitalization or CV death." Ann Intern Med. 2023 Apr;176(4):JC40. Show all (4)

Abstract 

Background

For patients with heart failure, reduced left ventricular ejection fraction and iron deficiency, intravenous ferric carboxymaltose administration improves quality of life and exercise capacity in the short-term and reduces hospital admissions for heart failure up to 1 year. We aimed to evaluate the longer-term effects of intravenous ferric derisomaltose on cardiovascular events in patients with heart failure.

Methods

IRONMAN was a prospective, randomised, open-label, blinded-endpoint trial done at 70 hospitals in the UK. Patients aged 18 years or older with heart failure (left ventricular ejection fraction ≤45%) and transferrin saturation less than 20% or serum ferritin less than 100 μg/L were eligible. Participants were randomly assigned (1:1) using a web-based system to intravenous ferric derisomaltose or usual care, stratified by recruitment context and trial site. The trial was open label, with masked adjudication of the outcomes. Intravenous ferric derisomaltose dose was determined by patient bodyweight and haemoglobin concentration. The primary outcome was recurrent hospital admissions for heart failure and cardiovascular death, assessed in all validly randomly assigned patients. Safety was assessed in all patients assigned to ferric derisomaltose who received at least one infusion and all patients assigned to usual care. A COVID-19 sensitivity analysis censoring follow-up on Sept 30, 2020, was prespecified. IRONMAN is registered with ClinicalTrials.gov, NCT02642562.

Findings

Between Aug 25, 2016, and Oct 15, 2021, 1869 patients were screened for eligibility, of whom 1137 were randomly assigned to receive intravenous ferric derisomaltose (n=569) or usual care (n=568). Median follow-up was 2·7 years (IQR 1·8-3·6). 336 primary endpoints (22·4 per 100 patient-years) occurred in the ferric derisomaltose group and 411 (27·5 per 100 patient-years) occurred in the usual care group (rate ratio [RR] 0·82 [95% CI 0·66 to 1·02]; p=0·070). In the COVID-19 analysis, 210 primary endpoints (22·3 per 100 patient-years) occurred in the ferric derisomaltose group compared with 280 (29·3 per 100 patient-years) in the usual care group (RR 0·76 [95% CI 0·58 to 1·00]; p=0·047). No between-group differences in deaths or hospitalisations due to infections were observed. Fewer patients in the ferric derisomaltose group had cardiac serious adverse events (200 [36%]) than in the usual care group (243 [43%]; difference -7·00% [95% CI -12·69 to -1·32]; p=0·016).

Interpretation

For a broad range of patients with heart failure, reduced left ventricular ejection fraction and iron deficiency, intravenous ferric derisomaltose administration was associated with a lower risk of hospital admissions for heart failure and cardiovascular death, further supporting the benefit of iron repletion in this population.

Funding

British Heart Foundation and Pharmacosmos.

Full text links 

Read article at publisher's site: https://doi.org/10.1016/s0140-6736(22)02083-9

Read article for free, from open access legal sources, via Unpaywall: https://figshare.com/articles/journal_contribution/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_/21623166/1/files/42568975.pdfUnpaywall

Citations & impact 

Impact metrics

64
Citations
Jump to Citations

Citations of article over time

Alternative metrics

Altmetric item for https://www.altmetric.com/details/138107507
Altmetric
Discover the attention surrounding your research
https://www.altmetric.com/details/138107507

Smart citations by scite.ai
Smart citations by scite.ai include citation statements extracted from the full text of the citing article. The number of the statements may be higher than the number of citations provided by EuropePMC if one paper cites another multiple times or lower if scite has not yet processed some of the citing articles.
Explore citation contexts and check if this article has been supported or disputed.
https://scite.ai/reports/10.1016/s0140-6736(22)02083-9

Supporting
Mentioning
Contrasting
4
111
0

Article citations

Go to all (64) article citations

Data 

Data behind the article

This data has been text mined from the article, or deposited into data resources.

Clinical Trials

Similar Articles 

To arrive at the top five similar articles we use a word-weighted algorithm to compare words from the Title and Abstract of each citation.

Funding 

Funders who supported this work.

British Heart Foundation (1)