Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN

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/CKD-EPI estimated glomerular filtration rate (eGFR) \<15ml/min/1.73m2
• •3. Already planned to receive IV iron
• •4. Likely to need or already receiving erythropoiesis stimulating agents (ESA)
• •5. 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.
• •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 \<2 years, active clinically relevant bleeding in the investigator's opinion, known or suspected gastro-intestinal malignancy
• •7. Pregnancy, women of childbearing potential (i.e. continuing menstrual cycle) not using effective contraception (see Appendix 3) or breast-feeding women
• •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 disease.
• •9. Participation in another intervention study involving a drug or device within the past 90 days (co-enrolment in observational studies is permitted)