Table 1.

Summary of key inclusion and exclusion criteria at screening

Key inclusion criteria	Key exclusion criteria
NYHA II–III functional class due to stable symptomatic CHF and all of the following	Known active infection, C-reactive protein>20 mg/L, clinically significant bleeding, active malignancy
Two weeks without cardiac hospitalization	ALT or AST >3× upper limit of normal
Patients in NYHA II: acute care admission or emergency room visit for worsening heart failure within 24 months prior to start of treatment	Anaemia due to reasons other than iron deficiency (e.g. haemoglobinopathy)
On optimal pharmacological treatment which includes a diuretic, a beta-blocker, and/or an ACE-inhibitor or ARB as determined by the investigator, unless contraindicated or not tolerated	Immunosuppressive therapy or renal dialysis
No dose changes of heart failure drugs during the last 2 weeks (exception: diuretics)	History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months
No introduction of a new heart failure drug class during the last 4 weeks	Unstable angina pectoris, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy
LVEF ≤40% for patients in NYHA II and LVEF ≤ 45% in NYHA III	Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months
Hb: 9.5–13.5 g/dL	Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months
Evidence of absolute or functional iron deficiency: screening ferritin <100 ng/mL or 100–300 ng/mL when TSAT < 20%
Patient must be able to perform the 6 minute walk test according to investigator judgement

ACE, angiotensin-converting enzyme; ALT, alanine transaminase; ARB, angiotensin II receptor blocker; AST, aspartate transaminase; CHF, chronic heart failure; Hb, haemoglobin; i.v., intravenous; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; TSAT, transferrin saturation.