Iron in Congestive Heart Failure (iCHF)

May 11, 2016 updated by: Dr. Mahir Karakas, University of Ulm

Randomized, Double-blind, Placebo-controlled Trial of Ferric Carboxymaltose Versus Placebo in Patients With Congestive Heart Failure

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • University of Aachen
      • Hamburg, Germany, 20251
        • University Heart Center Hamburg
      • Ulm, Germany, 89081
        • University of Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Iron
ferric carboxymaltose
Drug: ferric carboxymaltose
Other Names:
  • Ferinject
Placebo Comparator: Placebo
Sodium chloride 0.9%
Drug: Placebo
Other Names:
  • Sodium chloride 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Collaborators

RWTH Aachen University
Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Mahir Karakas, MD, University of Ulm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 17, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (Estimate)

April 22, 2013

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iCHF_D.3874
  • 2012-001134-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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