Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
18 participants
INTERVENTIONAL
2013-04-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Iron
ferric carboxymaltose
ferric carboxymaltose
Placebo
Sodium chloride 0.9%
Placebo
Interventions
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ferric carboxymaltose
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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RWTH Aachen University
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
University of Ulm
OTHER
Responsible Party
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Dr. Mahir Karakas
Dr. med.
Principal Investigators
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Mahir Karakas, MD
Role: PRINCIPAL_INVESTIGATOR
University of Ulm
Locations
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University of Aachen
Aachen, , Germany
University Heart Center Hamburg
Hamburg, , Germany
University of Ulm
Ulm, , Germany
Countries
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Other Identifiers
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2012-001134-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
iCHF_D.3874
Identifier Type: -
Identifier Source: org_study_id
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