Effectiveness of Intravenous Iron Treatment vs Standard Care in Patients With Heart Failure and Iron Deficiency: a Randomised, Open-label Multicentre Trial (IRONMAN)

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Effectiveness of Intravenous Iron Treatment vs Standard Care in Patients With Heart Failure and Iron Deficiency: a Randomised, Open-label Multicentre Trial (IRONMAN)

Condition: Heart Failure, Iron Deficiency, Left Ventricular Systolic Dysfunction

Intervention:

  • Drug: Iron (III) isomaltoside 1000

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02642562

Sponsor: University of Glasgow

Primary Outcome Measures:

  • Measure: CV mortality or hospitalisation for worsening heart failure (analysis will include first and recurrent hospitalisations)
  • Time Frame: Minimum 2.5 years follow up from last patient recruited
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: CV mortality
  • Time Frame: Minimum 2.5 years follow up from last patient recruited
  • Safety Issue:
  • Measure: Hospitalisation for worsening heart failure (analysis will include first and recurrent hospitalisations)
  • Time Frame: Minimum 2.5 years follow up from last patient recruited
  • Safety Issue:
  • Measure: All-cause mortality
  • Time Frame: Minimum 2.5 years follow up from last patient recruited
  • Safety Issue:
  • Measure: CV mortality or first hospitalisation for major CV event (stroke, myocardial infarction [MI], heart failure)
  • Time Frame: Minimum 2.5 years follow up from last patient recruited
  • Safety Issue:
  • Measure: Physical domain of QoL (Minnesota Living With Heart Failure and EQ-5D) – this will be the difference between groups at 4 months and also at 20 months
  • Time Frame: Minimum 2.5 years follow up from last patient recruited
  • Safety Issue:
  • Measure: Overall QoL assessment (Minnesota Living With Heart Failure and EQ-5D) – this will be the difference between groups at 4 months and also at 20 months
  • Time Frame: Minimum 2.5 years follow up from last patient recruited
  • Safety Issue:
  • Measure: Combined all-cause mortality or first all-cause unplanned hospitalisation
  • Time Frame: Minimum 2.5 years follow up from last patient recruited
  • Safety Issue:
  • Measure: Days dead or hospitalised at 2.5 years (minimum duration of follow-up)
  • Time Frame: Minimum 2.5 years follow up from last patient recruited
  • Safety Issue:
  • Measure: Quality-adjusted days alive and out of hospital at 2.5 years
  • Time Frame: Minimum 2.5 years follow up from last patient recruited
  • Safety Issue:
  • Measure: CV hospitalisation (first event)
  • Time Frame: Minimum 2.5 years follow up from last patient recruited
  • Safety Issue:
  • Measure: All-cause hospitalisation (first event)
  • Time Frame: Minimum 2.5 years follow up from last patient recruited
  • Safety Issue:
  • Measure: Death due to sepsis
  • Time Frame: Minimum 2.5 years follow up from last patient recruited
  • Safety Issue:
  • Measure: Hospitalisation primarily for infection
  • Time Frame: Minimum 2.5 years follow up from last patient recruited
  • Safety Issue:

Estimated Enrollment: 1300

Study Start Date: August 2016

Phase: Phase 4

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • 1. Age ≥18 years 2. LVEF <45% within the last 6 months using any conventional imaging modality 3. New York Heart Association (NYHA) class II
  • IV 4. Iron deficient
  • defined as TSAT <20% and/or ferritin
  • Current (with intention to discharge in next 48 hours) or recent (within 6 months) hospitalisation for HF, or
  • 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) 6. Able and willing to provide informed consent

Exclusion Criteria:

  • 1. 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) 2. MDRD estimated glomerular filtration rate (eGFR) <15ml/min/1.73m2 3. Chronic defined need for IV iron therapy 4. Likely to need or already receiving erythropoiesis stimulating agents (ESA) 5. Planned cardiac surgery or revascularisation or cardiac device implantation; within 3 months of 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), cardiac device implantation or blood transfusion; on active cardiac transplant list; left ventricular assist device implanted 6. 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
  • see Appendix 3. 8. 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 cirrhosis and hepatitis 9. Participation in another intervention study involving a drug or device within the past 90 days (co-enrolment in observational studies is permitted)

Contact:

  • Paul Kalra, MA MB BChir MD
  • 02392 283650

Locations:

  • Aberdeen Royal Infirmary
  • Aberdeen United Kingdom
  • Monklands Hospital
  • Airdrie United Kingdom
  • Antrim Area Hospital
  • Antrim United Kingdom
  • Wansbeck General Hospital
  • Ashington United Kingdom
  • Barnet Hospital
  • Barnet United Kingdom
  • Basingstoke and North Hampshire Hospital
  • Basingstoke United Kingdom
  • Blackpool Hospital
  • Blackpool United Kingdom
  • Royal Bournemouth Hospital
  • Bournemouth United Kingdom
  • Bradford Royal Infirmary
  • Bradford United Kingdom
  • Royal Sussex County Hospital
  • Brighton United Kingdom
  • Chesterfield Royal Hospital
  • Chesterfield United Kingdom
  • University Hospital Coventry
  • Coventry United Kingdom
  • County Durham and Darlington NHS Foundation Trust
  • Darlington United Kingdom
  • Dumfries and Galloway Royal Infirmary
  • Dumfries United Kingdom
  • Ninewells Hospital
  • Dundee United Kingdom
  • Ulster Hospital
  • Dundonald United Kingdom
  • Hairmyres Hospital
  • East Kilbride 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
  • Royal Brompton and Harefield NHS Trust
  • 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
  • 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
  • Royal Glamorgan Hospital
  • Llantrisant United Kingdom
  • Hammersmith Hospital (Imperial College)
  • London United Kingdom
  • King’s College Hospital
  • London United Kingdom
  • North Middlesex University Hospital
  • London United Kingdom
  • University College London Hospitals
  • London United Kingdom
  • Manchester Royal Infirmary
  • Manchester United Kingdom
  • Wythenshawe Hospital
  • Manchester United Kingdom
  • Royal Gwent Hospital
  • Newport United Kingdom
  • Royal Alexandra Hospital
  • Paisley United Kingdom
  • Queen Alexandra Hospital
  • Portsmouth United Kingdom
  • Salford Royal Hospital
  • Salford United Kingdom
  • Sheffield Teaching Hospital NHS Foundation Trust
  • Sheffield United Kingdom
  • University Hospital Southampton
  • Southampton United Kingdom
  • Southend University Hospital
  • Southend United Kingdom
  • City Hospitals Sunderland
  • Sunderland United Kingdom
  • Great Western Hospital
  • Swindon United Kingdom
  • Princess Royal Hospital
  • Telford United Kingdom

View trial on ClinicalTrials.gov

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