Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality

Prior treatment

• Use of renal replacement therapy
• Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 6 weeks prior to randomisation.

Other illness

• Hypersensitivity to the active substance, to FCM or any of its excipients
• Known serious hypersensitivity to other parenteral iron products
• History of severe asthma with known FEV1 \<50%
• Acute bacterial infection

Lab values

• Presence of a deficiency for vitamin B12 and/or serum folate (if present, this needs to be corrected first)

Other

• Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia
• Evidence of iron overload or disturbances in the utilisation of iron
• More than 500 meters in the initial 6-minutes walking-test

• Patients with chronic HFrEF (CHF) of at least 3 months duration and a history of documented LVEF\<45%.
• Confirmed presence of ID (ferritin \< 100 ng/mL or ferritin 100 - 299 ng/mL with TSAT \< 20 %)
• Serum haemoglobin of 9.5 - 14.0 g/dL
• At time of screening considered re-stabilised and planned for discharge within next 24 h (NYHA 2 or 3), or stable ambulatory with a HF hospitalisation in the past 12 months (NYHA 2-4), or stable ambulatory with BNP \> 100 pg/mL or NT-proBNP \> 300 pg/mL or MR-proANP \> 120 pmol/L (NYHA 2-4)
• Written informed consent