Changes in Myocardial Iron After Iron Administration

Inclusion criteria

• Patients with ambulatory chronic heart failure
• Older than 18 years
• Patients in NYHA class II-III on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of HF drugs during the last 2 weeks (with the exception of diuretics)
• Elevated natriuretic peptides levels (NT-proBNP >400 pg/ml) at the screening visit
• Left ventricle ejection fraction <50% documented in the last 12 months
• Iron deficiency defined as: serum ferritin level <100 μg/L or ferritin level 100-299 μg/L when TSAT is less than 20%, and hemoglobin <15 g/dL (all at screening)
• Participant is willing and able to give informed consent for participation in the study

Exclusion criteria

• Known sensitivity to any of the products to be administered per protocol.
• History of acquired iron overload.
• Severe valve disease, or being scheduled for cardiac surgery within the next 30 days.
• Acute myocardial infarction or acute coronary syndrome, transient ischemic attack, or stroke within the last 3 months prior to randomization.
• Coronary artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, and aortic; diagnostic catheters are allowed), or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomization.
• Ischemic heart disease scheduled for revascularization procedures within the next 30 days.
• HF scheduled for cardiac resynchronization therapy within the next 30 days.
• Patients with active bleeding in the last 30 days.
• Known active infection or active malignancy.
• Subject at an immediate need of transfusion or hemoglobin ≥15 g/dL.
• Anemia due to reasons other than iron deficiency
• Immunosuppressive therapy or renal dialysis
• History of erythropoietin, intravenous iron therapy, and blood transfusion in the previous 12 weeks.
• Oral iron therapy at doses >100 mg/day in previous 1 week prior to randomization.
• Subjects with an immediate need for transfusion.
• Pregnant or breastfeeding women.
• Subject of childbearing potential who is not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
• Subject currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study, or subject is receiving other investigational agent(s).
• Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.