Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN
IRONMAN
Effectiveness of Intravenous Iron Treatment vs Standard Care in Patients With Heart Failure and Iron Deficiency: a Randomised, Open-label Multicentre Trial (IRONMAN)
1 other identifier
interventional
1,160
1 country
72
Brief Summary
This study will address whether the additional use of Intravenous (IV) iron on top of standard care will improve the outlook for patients with heart failure and iron deficiency. One group of participants will receive treatment with iron injections and the other group will not receive any iron injections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2016
Longer than P75 for phase_4
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2015
CompletedFirst Posted
Study publicly available on registry
December 30, 2015
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2022
CompletedOctober 28, 2022
October 1, 2022
6.1 years
December 24, 2015
October 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CV mortality or hospitalisation for worsening heart failure (analysis will include first and recurrent hospitalisations)
Minimum of 3 months follow-up from last patient recruited
Secondary Outcomes (22)
Hospitalisation for worsening heart failure (recurrent events)
Minimum of 3 months follow-up from last patient recruited
CV hospitalisation (first event)
Minimum of 3 months follow-up from last patient recruited
CV death or hospitalisation for heart failure analysed as time to first event
Minimum of 3 months follow-up from last patient recruited
Overall Score from Minnesota Living with Heart Failure
At 4 months
Cardiovascular mortality
Minimum of 3 months follow-up from last patient recruited
- +17 more secondary outcomes
Study Arms (2)
Standard care
NO INTERVENTIONParticipants in this arm will receive their usual care
Standard care plus IV iron infusion
EXPERIMENTALIron to be administered as iron (III) isomaltoside 1000 / ferric derisomaltose. Infused over a minimum of 15 mins for doses up to and including 1000mg, and a minimum of 30 mins for doses \>1000mg Where Hb ≥10 g/dL, dosage according to body weight is as follows: Body weight \<50 kg: 20 mg/kg; Body weight 50 to \<70 kg: 1000 mg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 1500 mg. Where Hb \<10 g/dL, dosage according to body weight is as follows: Body weight \<50 kg: 20 mg/kg; Body weight 50 to \<70 kg: 20 mg/kg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 2000 mg.
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- LVEF ≤45% within the prior two years using any conventional imaging modality (this should be the most recent assessment of LVEF)
- New York Heart Association (NYHA) class II - IV
- Iron deficient - defined as TSAT \<20% and/or ferritin \<100 ug/L
- Evidence of being in a higher risk HF group: (a) Current (with the expectation that patient will survive to discharge) or recent (within 6 months) hospitalisation for HF, OR (b) Out-patients with NT-proBNP \>250 ng/L in sinus rhythm or \>1,000 ng/L in atrial fibrillation (or BNP of \> 75 pg/mL or 300 pg/mL, respectively)
- Able and willing to provide informed consent
You may not qualify if:
- Haematological criteria: ferritin \>400ug/L; haemoglobin \<9.0, or \>13 g/dL in women or \>14g/dL in men; (B12 or folate deficiency should be corrected but do not exclude the patient)
- MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \<15ml/min/1.73m2
- Already planned to receive IV iron
- Likely to need or already receiving erythropoiesis stimulating agents (ESA)
- Any of the following apply: (a) planned cardiac surgery or revascularisation; (b) within 3 months of any of the following: a primary diagnosis of type 1 myocardial infarction (excluding small troponin elevations in the context of heart failure admissions), cerebrovascular accident (CVA), major CV surgery or percutaneous coronary intervention (PCI), or blood transfusion; (c) on active cardiac transplant list; (d) left ventricular assist device implanted.
- Any of the following comorbidities: active infection (if the patient is suffering from a significant ongoing infection as judged by the investigator recruitment should be postponed until the infection has passed or is controlled by antibiotics), other disease with life expectancy of \<2 years, active clinically relevant bleeding in the investigator's opinion, known or suspected gastro-intestinal malignancy
- Pregnancy, women of childbearing potential (i.e. continuing menstrual cycle) not using effective contraception (see Appendix 3) or breast-feeding women
- Contra-indication to IV iron in the investigator's opinion according to current approved Summary of Product Characteristics: hypersensitivity to the active substance, to Monofer® or any of its excipients (water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment)); known serious hypersensitivity to other parenteral iron products; non-iron deficiency anaemia (e.g. haemolytic anaemia); iron overload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis); decompensated liver disease.
- Participation in another intervention study involving a drug or device within the past 90 days (co-enrolment in observational studies is permitted)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Glasgowlead
- NHS Greater Glasgow and Clydecollaborator
- Pharmacosmos A/Scollaborator
- British Heart Foundationcollaborator
Study Sites (72)
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
University Hospital Monklands
Airdrie, United Kingdom
Antrim Area Hospital
Antrim, United Kingdom
Wansbeck General Hospital
Ashington, United Kingdom
Barnet Hospital
Barnet, United Kingdom
Basildon University Hospital
Basildon, United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke, United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Bradford Royal Infirmary
Bradford, United Kingdom
Princess of Wales Hospital
Bridgend, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Broomfield Hospital
Chelmsford, United Kingdom
Chesterfield Royal Hospital
Chesterfield, United Kingdom
St. Richard's Hospital
Chichester, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Croydon University Hospital
Croydon, United Kingdom
Darlington Memorial Hospital
Darlington, United Kingdom
Doncaster Royal Infirmary
Doncaster, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Ulster Hospital
Dundonald, United Kingdom
Eastbourne District General Hospital
Eastbourne, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
Golden Jubilee National Hospital
Glasgow, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Harefield Hospital
Harefield, United Kingdom
Wycombe General Hospital
High Wycombe, United Kingdom
Castle Hill Hospital
Hull, United Kingdom
Raigmore Hospital
Inverness, United Kingdom
West Middlesex University Hospital
Isleworth, United Kingdom
University Hospital Crosshouse
Kilmarnock, United Kingdom
Kingston Hospital
Kingston upon Thames, United Kingdom
Victoria Hospital
Kirkcaldy, United Kingdom
Forth Valley Royal Hospital
Larbert, United Kingdom
Glenfield Hospital
Leicester, United Kingdom
Aintree University Hospital
Liverpool, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
University Hospital Llandough
Llandough, United Kingdom
Royal Glamorgan Hospital
Llantrisant, United Kingdom
Guy's and St. Thomas' Hospital
London, United Kingdom
Hammersmith Hospital (Imperial College)
London, United Kingdom
King's College Hospital
London, United Kingdom
North Middlesex University Hospital
London, United Kingdom
St. Bartholomew's Hospital
London, United Kingdom
University College London Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Wythenshawe Hospital
Manchester, United Kingdom
Royal Gwent Hospital
Newport, United Kingdom
Nottingham University Hospital
Nottingham, United Kingdom
Royal Oldham Hospital
Oldham, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Royal Alexandra Hospital
Paisley, United Kingdom
Poole Hospital
Poole, United Kingdom
Queen Alexandra Hospital
Portsmouth, United Kingdom
Salford Royal Hospital
Salford, United Kingdom
Salisbury District Hospital
Salisbury, United Kingdom
Northern General Hospital
Sheffield, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Southend University Hospital
Southend, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
City Hospitals Sunderland
Sunderland, United Kingdom
Morriston Hospital
Swansea, United Kingdom
Great Western Hospital
Swindon, United Kingdom
St. George's Hospital
Tooting, United Kingdom
Torbay Hospital
Torquay, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Watford General Hospital
Watford, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
Related Publications (5)
Sze S, Squire I, Kalra PR, Cleland JG, Petrie MC, Kalra PA, Ahmed F, Banerjee P, Boos CJ, Chapman C, Cowburn PJ, Dixon L, Duckett S, Lane R, Foley P, Lang NN, Lyons K, Ray R, Schiff R, Thomson EA, Robertson M, Ford I; IRONMAN Study group. Age-stratified effects of intravenous ferric derisomaltose in heart failure with iron deficiency: insights from the IRONMAN trial. Heart. 2025 Jun 13;111(13):634-641. doi: 10.1136/heartjnl-2024-324908.
PMID: 39938943DERIVEDFoley PW, Kalra PR, Cleland JGF, Petrie MC, Kalra PA, Squire I, Campbell P, Chapman C, Donnelly P, Graham F, Hannah A, Lang NN, Matthews I, Leslie SJ, Pellicori P, Piper S, Ray R, Savage HO, Spencer C, Walsh J, Wong YK, Ford I; on behalf of the IRONMAN Study Group. Effect of correcting iron deficiency on the risk of serious infection in heart failure: Insights from the IRONMAN trial. Eur J Heart Fail. 2025 Jan;27(1):166-173. doi: 10.1002/ejhf.3504. Epub 2024 Oct 25.
PMID: 39453738DERIVEDCleland JGF, Pellicori P, Graham FJ, Lane R, Petrie MC, Ahmed F, Squire IB, Ludman A, Japp A, Al-Mohammad A, Clark AL, Szwejkowski B, Critoph C, Chong V, Schiff R, Nageh T, Glover J, McMurray JJV, Thomson EA, Robertson M, Ford I, Kalra PA, Kalra PR; IRONMAN Study Group. Adjudication of Hospitalizations and Deaths in the IRONMAN Trial of Intravenous Iron for Heart Failure. J Am Coll Cardiol. 2024 Oct 29;84(18):1704-1717. doi: 10.1016/j.jacc.2024.08.052.
PMID: 39443013DERIVEDKalra PR, Cleland JGF, Petrie MC, Thomson EA, Kalra PA, Squire IB, Ahmed FZ, Al-Mohammad A, Cowburn PJ, Foley PWX, Graham FJ, Japp AG, Lane RE, Lang NN, Ludman AJ, Macdougall IC, Pellicori P, Ray R, Robertson M, Seed A, Ford I; IRONMAN Study Group. 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. doi: 10.1016/S0140-6736(22)02083-9. Epub 2022 Nov 5.
PMID: 36347265DERIVEDKalra PR, Cleland JG, Petrie MC, Ahmed FZ, Foley PW, Kalra PA, Lang NN, Lane RE, Macdougall IC, Pellicori P, Pope MTB, Robertson M, Squire IB, Thomson EA, Ford I. Rationale and design of a randomised trial of intravenous iron in patients with heart failure. Heart. 2022 Nov 24;108(24):1979-1985. doi: 10.1136/heartjnl-2022-321304.
PMID: 35948408DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nicholas Boon
Chair of Steering Committee (Retired)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Investigator
Study Record Dates
First Submitted
December 24, 2015
First Posted
December 30, 2015
Study Start
August 1, 2016
Primary Completion
August 26, 2022
Study Completion
August 26, 2022
Last Updated
October 28, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Applications for access will be considered when analysis of the main pre-specified endpoints, sub-groups and sub-studies, and other sub-analyses have been completed.
- Access Criteria
- Applications for access will be reviewed by the study Steering Committee.
Applications for data access will be considered when analysis of the main pre-specified endpoints, sub-groups and sub-studies, and other sub-analyses have been completed.