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

A Randomised, Controlled, Observer-blinded Phase III Clinical Trial to Compare the Effect of Intravenous Ferric Carboxymaltose to Placebo on Exercise Capacity and Cardiac Function in Patients With Chronic Heart Failure and Iron Deficiency

This study is designed to assess, relative to placebo, the effects on the evolution of exercise capacity and symptomatic status of the addition of iron treatment with FCM (ferric carboxymaltose) to the basic regimen of ambulatory patients with stable symptomatic chronic CHF (congestive heart failure) and iron deficiency.

Inclusion Criteria:

• In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic 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 (average of 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 aspartate transaminase (AST)
• Anaemia due to reasons other than iron deficiency
• Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
• 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.
• Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.
• Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months.
• 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.