Iron in Congestive Heart Failure

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Ulm
• Collaborators: RWTH Aachen University; Universitätsklinikum Hamburg-Eppendorf
• Treatments: Ferric Compounds

Criteria

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