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Trial record 81 of 380 for:    FERRIC CATION

Iron in Congestive Heart Failure (iCHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01837082
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : April 22, 2013
Last Update Posted : May 13, 2016
Sponsor:
Collaborators:
RWTH Aachen University
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Dr. Mahir Karakas, 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.

Condition or disease Intervention/treatment Phase
Heart Failure Iron Deficiency Anemia Drug: ferric carboxymaltose Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled Trial of Ferric Carboxymaltose Versus Placebo in Patients With Congestive Heart Failure
Study Start Date : April 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron

Arm Intervention/treatment
Active Comparator: Iron
ferric carboxymaltose
Drug: ferric carboxymaltose
Other Name: Ferinject

Placebo Comparator: Placebo
Sodium chloride 0.9%
Drug: Placebo
Other Name: Sodium chloride 0.9%




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837082


Locations
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Germany
University of Aachen
Aachen, Germany, 52074
University Heart Center Hamburg
Hamburg, Germany, 20251
University of Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
University of Ulm
RWTH Aachen University
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Mahir Karakas, MD University of Ulm

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Responsible Party: Dr. Mahir Karakas, Dr. med., University of Ulm
ClinicalTrials.gov Identifier: NCT01837082     History of Changes
Other Study ID Numbers: iCHF_D.3874
2012-001134-33 ( EudraCT Number )
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Keywords provided by Dr. Mahir Karakas, University of Ulm:
Heart Failure
Iron Deficiency
Anemia
Ferric Carboxymaltose
Additional relevant MeSH terms:
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Ferric Compounds
Heart Failure
Anemia, Iron-Deficiency
Heart Diseases
Cardiovascular Diseases
Anemia
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Hematinics