Status:
TERMINATED
Iron in Congestive Heart Failure
Lead Sponsor:
University of Ulm
Collaborating Sponsors:
RWTH Aachen University
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Heart Failure
Iron Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 det...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01837082
Start Date
April 1 2013
End Date
December 1 2015
Last Update
May 13 2016
Active Locations (3)
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1
University of Aachen
Aachen, Germany, 52074
2
University Heart Center Hamburg
Hamburg, Germany, 20251
3
University of Ulm
Ulm, Germany, 89081