Iron in Congestive Heart Failure

Randomized, Double-blind, Placebo-controlled Trial of Ferric Carboxymaltose Versus Placebo in Patients With Congestive Heart Failure

The hypothesis to be tested is whether treatment with intravenous iron (ferric carboxymaltose) will improve left-ventricular ejection fraction in patients with heart failure and iron deficiency as determined by cardiac magnetic resonance imaging.

Inclusion Criteria:

• Congestive heart failure
• At least 18 years of age
• Iron deficiency
• Dyspnea class II or III according to New York Heart Association
• Left-ventricular ejection fraction ≤ 45%

Exclusion Criteria:

• Known sensitivity to any of the products to be administered during dosing
• Immediate need of transfusion
• Patients presenting with an active infection
• Thalassaemia
• Other forms of microcytic anemia not caused by iron deficiency
• History of acquired iron overload
• Need for revascularization, ST-segment elevation myocardial infarction or Non-ST-segment elevation myocardial infarction during the past 3 months (at time of randomization)
• Women who are pregnant or of childbearing age and not using medically acceptable effective contraception