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

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Intravenous iron, PROBE design Read More

Inclusion criteria

1. Age ≥18 years
2. LVEF ≤45% within the prior two years using any conventional imaging modality (this should be the most recent assessment of LVEF)
3. New York Heart Association (NYHA) class II - IV
4. Iron deficient - defined as TSAT <20% and/or ferritin <100 ug/L
5. 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)
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/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)