Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure (EFFECT-HF)

• Iron Deficiency
• Chronic Heart Failure

• Drug: Ferinject (ferric carboxymaltose)
  Subjects will receive ferric carboxymaltose intravenously on Day 0, Week 6, and Week 12
• Other: Standard of Care
  Subjects randomised to Standard of Care may receive oral iron at Investigator's discretion however patients will not be permitted to receive IV iron

• Experimental: Ferinject (ferric carboxymaltose)
  Intervention: Drug: Ferinject (ferric carboxymaltose)
• Standard of Care
  Standard of care. IV iron is not permitted
  Intervention: Other: Standard of Care

Inclusion Criteria:

• Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
• Reduced exercise capacity
• Reduced left ventricular ejection fraction
• At least 18 years of age and with written informed consent prior to any study specific procedures

Exclusion Criteria:

• Erythropoietin stimulating agent (ESA) use, IV iron therapy, and/or blood transfusion in previous 6 weeks prior to randomisation
• Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
• Chronic liver disease and/or elevated liver enzymes
• Vitamin B12 and/or serum folate deficiency
• Subject is not using adequate contraceptive precautions during the study
• No other significant cardiac or general disorder that would compromise participation in the study