Iron in Congestive Heart Failure

Phase 3TerminatedNCT01837082

University of Ulm18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Heart Failure Iron Deficiency Anemia

Interventions

ferric carboxymaltoseDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

University of Aachen

Aachen, Germany

University Heart Center Hamburg

Hamburg, Germany

University of Ulm

Ulm, Germany

Outcomes

Primary Outcomes

The primary endpoint of the study is the change from baseline to week 12 in left-ventricular ejection fraction as determined by cardiac magnetic resonance imaging.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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