Chronic Heart FailurePhase 4IRONMANNCT02642562
Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN
A Phase 4 study testing Ferric Derisomaltose in people with Chronic Heart Failure and Iron Deficiency, run by University of Glasgow at 72 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Iron Deficiency, Left Ventricular Systolic Dysfunction
- What is being tested?
- Ferric Derisomaltose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,160 participants
- Where
- 72 sitesUnited Kingdom
- Study dates
- Aug 2016to 26 Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
72 sites in 1 country.
72 sites in 1 country
United Kingdom72 sites
Aberdeen Royal Infirmary
Aberdeen
University Hospital Monklands
Airdrie
Antrim Area Hospital
Antrim
Wansbeck General Hospital
Ashington
Barnet Hospital
Barnet
Basildon University Hospital
Basildon
Basingstoke and North Hampshire Hospital
Basingstoke
Royal Victoria Hospital
Belfast
Blackpool Victoria Hospital
Blackpool
Royal Bournemouth Hospital
Bournemouth
Bradford Royal Infirmary
Bradford
Princess of Wales Hospital
Bridgend
Royal Sussex County Hospital
Brighton
Bristol Royal Infirmary
Bristol
Broomfield Hospital
Chelmsford
Chesterfield Royal Hospital
Chesterfield
St. Richard's Hospital
Chichester
University Hospital Coventry
Coventry
Croydon University Hospital
Croydon
Darlington Memorial Hospital
Darlington
Doncaster Royal Infirmary
Doncaster
Ninewells Hospital
Dundee
Ulster Hospital
Dundonald
Eastbourne District General Hospital
Eastbourne
Royal Infirmary of Edinburgh
Edinburgh
Royal Devon and Exeter Hospital
Exeter
Glasgow Royal Infirmary
Glasgow
Golden Jubilee National Hospital
Glasgow
Queen Elizabeth University Hospital
Glasgow
Harefield Hospital
Harefield
Wycombe General Hospital
High Wycombe
Castle Hill Hospital
Hull
Raigmore Hospital
Inverness
West Middlesex University Hospital
Isleworth
University Hospital Crosshouse
Kilmarnock
Kingston Hospital
Kingston upon Thames
Victoria Hospital
Kirkcaldy
Forth Valley Royal Hospital
Larbert
Glenfield Hospital
Leicester
Aintree University Hospital
Liverpool
Liverpool Heart and Chest Hospital
Liverpool
University Hospital Llandough
Llandough
Royal Glamorgan Hospital
Llantrisant
Guy's and St. Thomas' Hospital
London
Hammersmith Hospital (Imperial College)
London
King's College Hospital
London
North Middlesex University Hospital
London
St. Bartholomew's Hospital
London
University College London Hospital
London
Manchester Royal Infirmary
Manchester
Wythenshawe Hospital
Manchester
Royal Gwent Hospital
Newport
Nottingham University Hospital
Nottingham
Royal Oldham Hospital
Oldham
John Radcliffe Hospital
Oxford
Royal Alexandra Hospital
Paisley
Poole Hospital
Poole
Queen Alexandra Hospital
Portsmouth
Salford Royal Hospital
Salford
Salisbury District Hospital
Salisbury
Northern General Hospital
Sheffield
University Hospital Southampton
Southampton
Southend University Hospital
Southend
Royal Stoke University Hospital
Stoke-on-Trent
City Hospitals Sunderland
Sunderland
Morriston Hospital
Swansea
Great Western Hospital
Swindon
St. George's Hospital
Tooting
Torbay Hospital
Torquay
Royal Cornwall Hospital
Truro
Watford General Hospital
Watford
New Cross Hospital
Wolverhampton
About this study
Official title: Effectiveness of Intravenous Iron Treatment vs Standard Care in Patients With Heart Failure and Iron Deficiency: a Randomised, Open-label Multicentre Trial (IRONMAN)
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.
Read the detailed description
Chronic heart failure (CHF) is a very common medical problem. Despite improvements in treatment, many patients suffer limiting symptoms of shortness of breath and fatigue. Hospitalisation for CHF is common and life expectancy reduced. Many patients with CHF have a deficiency of iron (low iron levels or cannot use iron properly), and this is associated with poorer outcomes. Some small research studies have suggested that giving patients intravenous iron improves symptoms in the short term. It is unknown, however, whether correcting iron deficiency is beneficial to patients with CHF in the long term and whether it improves life expectancy and keeps them out of hospital. This study will help us answer these key questions.
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.
The study will take place in about 70 secondary care sites (hospitals) across the UK. Participants will be recruited over a period of about five years and will be followed up for a minimum of three months (average duration of about four years per participant). After the initial visits, participants will be seen every four months.
- Being tested
- Ferric Derisomaltose
- Keywords
- Intravenous iron, PROBE design
- Medical subject headings
- Iron Deficiencies, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric DerisomaltoseDrug
Also called Monofer
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Participants in this arm will receive their usual care |
| Standard care plus IV iron infusion | Experimental | Iron 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. Receives: Drug: Ferric Derisomaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
CV mortality or hospitalisation for worsening heart failure (analysis will include first and recurrent hospitalisations)
Measured: Minimum of 3 months follow-up from last patient recruited
Secondary outcomes (22)
Hospitalisation for worsening heart failure (recurrent events)
Measured: Minimum of 3 months follow-up from last patient recruited
CV hospitalisation (first event)
Measured: Minimum of 3 months follow-up from last patient recruited
CV death or hospitalisation for heart failure analysed as time to first event
Measured: Minimum of 3 months follow-up from last patient recruited
Overall Score from Minnesota Living with Heart Failure
Measured: At 4 months
Cardiovascular mortality
Measured: Minimum of 3 months follow-up from last patient recruited
Overall EQ-5D VAS
Measured: At 4 months
Overall EQ-5D index
Measured: At 4 months
CV mortality or hospitalisation for major CV event (stroke, MI, heart failure) (first event)
Measured: Minimum of 3 months follow-up from last patient recruited
All-cause mortality
Measured: Minimum of 3 months follow-up from last patient recruited
All-cause hospitalisation (first event)
Measured: Minimum of 3 months follow-up from last patient recruited
Combined all-cause mortality or first all-cause unplanned hospitalisation
Measured: Minimum of 3 months follow-up from last patient recruited
Physical domain of QoL (Minnesota Living With Heart Failure)
Measured: At 4 months
Physical domain of QoL (Minnesota Living With Heart Failure)
Measured: At 20 months
Overall EQ-5D VAS
Measured: At 20 months
Overall EQ-5D index
Measured: At 20 months
Overall Score from Minnesota Living With Heart Failure
Measured: At 20 months
Days dead or hospitalised
Measured: At 36 months
Quality-adjusted days alive and out of hospital
Measured: At 12 months
6 minute walk test
Measured: At 4 months
6 minute walk test
Measured: At 20 months
Death due to infection
Measured: Minimum of 3 months follow-up from last patient recruited
Hospitalisation primarily for infection (first event)
Measured: Minimum of 3 months follow-up from last patient recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startAug 2016
- Primary completion26 Aug 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, Pharmacosmos A/S, British Heart Foundation
- Responsible party
- Principal investigator, Paul Kalra, University of Glasgow
- Investigators
- Nicholas Boon, Study chair, Chair of Steering Committee (Retired)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642562
- Sponsor's protocol ID
- GN15CA190
- Acronym
- IRONMAN
- Status last verified
- Oct 2022
- First submitted
- 24 Dec 2015
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39938943Foley 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.
PubMed 39453738Cleland 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.
PubMed 39443013Kalra 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.
PubMed 36347265Kalra 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.
PubMed 35948408
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intravenous Iron Treatment vs Standard Care in Patients With Heart Failure and Iron Deficiency: a Randomised, Open-label Multicentre Trial (IRONMAN)
- ClinicalTrials.gov ID
- NCT02642562
- Acronym / sponsor ID
- IRONMAN / GN15CA190
- Keywords
- Intravenous iron, PROBE design
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,160 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, Pharmacosmos A/S, British Heart Foundation
- Study start
- Aug 2016 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic heart failure (CHF) is a very common medical problem. Despite improvements in treatment, many patients suffer limiting symptoms of shortness of breath and fatigue. Hospitalisation for CHF is common and life expectancy reduced. Many patients with CHF have a deficiency of iron (low iron levels or cannot use iron properly), and this is associated with poorer outcomes. Some small research studies have suggested that giving patients intravenous iron improves symptoms in the short term. It is unknown, however, whether correcting iron deficiency is beneficial to patients with CHF in the long term and whether it improves life expectancy and keeps them out of hospital. This study will help us answer these key questions.
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.
The study will take place in about 70 secondary care sites (hospitals) across the UK. Participants will be recruited over a period of about five years and will be followed up for a minimum of three months (average duration of about four years per participant). After the initial visits, participants will be seen every four months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Participants in this arm will receive their usual care |
| Standard care plus IV iron infusion | Experimental | Drug: Ferric DerisomaltoseIron 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric DerisomaltoseAlso: Monofer | Drug | Standard care plus IV iron infusion |
Primary outcome
CV mortality or hospitalisation for worsening heart failure (analysis will include first and recurrent hospitalisations)
Time frame: Minimum of 3 months follow-up from last patient recruited
22 secondary outcomes
Hospitalisation for worsening heart failure (recurrent events)
Time frame: Minimum of 3 months follow-up from last patient recruited
CV hospitalisation (first event)
Time frame: Minimum of 3 months follow-up from last patient recruited
CV death or hospitalisation for heart failure analysed as time to first event
Time frame: Minimum of 3 months follow-up from last patient recruited
Overall Score from Minnesota Living with Heart Failure
Time frame: At 4 months
Cardiovascular mortality
Time frame: Minimum of 3 months follow-up from last patient recruited
Overall EQ-5D VAS
Time frame: At 4 months
Overall EQ-5D index
Time frame: At 4 months
CV mortality or hospitalisation for major CV event (stroke, MI, heart failure) (first event)
Time frame: Minimum of 3 months follow-up from last patient recruited
All-cause mortality
Time frame: Minimum of 3 months follow-up from last patient recruited
All-cause hospitalisation (first event)
Time frame: Minimum of 3 months follow-up from last patient recruited
Combined all-cause mortality or first all-cause unplanned hospitalisation
Time frame: Minimum of 3 months follow-up from last patient recruited
Physical domain of QoL (Minnesota Living With Heart Failure)
Time frame: At 4 months
Physical domain of QoL (Minnesota Living With Heart Failure)
Time frame: At 20 months
Overall EQ-5D VAS
Time frame: At 20 months
Overall EQ-5D index
Time frame: At 20 months
Overall Score from Minnesota Living With Heart Failure
Time frame: At 20 months
Days dead or hospitalised
Time frame: At 36 months
Quality-adjusted days alive and out of hospital
Time frame: At 12 months
6 minute walk test
Time frame: At 4 months
6 minute walk test
Time frame: At 20 months
Death due to infection
Time frame: Minimum of 3 months follow-up from last patient recruited
Hospitalisation primarily for infection (first event)
Time frame: Minimum of 3 months follow-up from last patient recruited
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Derived from this study: PubMed 39938943Sze 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.
- Derived from this study: PubMed 39453738Foley 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.
- Derived from this study: PubMed 39443013Cleland 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.
- Derived from this study: PubMed 36347265Kalra 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.
- Derived from this study: PubMed 35948408Kalra 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Boon study chair
Chair of Steering Committee (Retired)
72 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric Derisomaltose in people with Chronic Heart Failure and Iron Deficiency, run by University of Glasgow at 72 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CV mortality or hospitalisation for worsening heart failure (analysis will include first and recurrent hospitalisations) (time frame: Minimum of 3 months follow-up from last patient recruited). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02642562, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.