EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure

Inclusion Criteria:

• In New York Heart Association (NYHA) II-III functional class due to stable symptomaticchronic heart failure (CHF)

• Left ventricular ejection fraction (LVEF) 40% or lower for patients in NYHA II and 45%or lower in NYHA III

• Screening haemoglobin (Hb) at least 9.5 g/dL but below or equal to 13.5 g/dL (averageof 2 haemoglobin concentrations)

• Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%

Exclusion Criteria:

• History of acquired iron overload.

• Known active infection, clinically significant bleeding, active malignancy.

• Chronic liver disease and/or screening alanine transaminase (ALT) or aspartatetransaminase (AST)

• Anaemia due to reasons other than iron deficiency

• Immunosuppressive therapy or renal dialysis (current or planned within the next 6months).

• History of erythropoietin, i.v. or oral iron therapy, and blood transfusion inprevious 12 weeks and/or such therapy planned within the next 6 months.

• Unstable angina pectoris as judged by the investigator, clinically significantuncorrected valvular disease or left ventricular outflow obstruction, obstructivecardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorlycontrolled symptomatic brady- or tachyarrhythmias.

• Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack orstroke within the last 3 months.

• Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac,cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, includingthoracic and cardiac surgery, within the last 3 months.