Iron in Congestive Heart Failure

Phase 3

Terminated

• Conditions: Heart Failure; Iron Deficiency; Anemia
• Interventions: Drug: ferric carboxymaltose; Drug: Placebo

• Registration Number: NCT01837082
• Lead Sponsor: University of Ulm

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-22
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron	ferric carboxymaltose	ferric carboxymaltose
Placebo	Placebo	Sodium chloride 0.9%

Primary Outcome Measures

Name	Time	Method
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.	12 weeks

Trial Locations

Locations (3)

University of Ulm; 🇩🇪 Ulm, Germany

University of Aachen; 🇩🇪 Aachen, Germany

University Heart Center Hamburg; 🇩🇪 Hamburg, Germany