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Iron in Congestive Heart Failure (iCHF)

Primary Purpose

Heart Failure, Iron Deficiency, Anemia

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
ferric carboxymaltose
Placebo
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Iron Deficiency, Anemia, Ferric Carboxymaltose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Aachen
  • University Heart Center Hamburg
  • University of Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Iron

Placebo

Arm Description

ferric carboxymaltose

Sodium chloride 0.9%

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2013
Last Updated
May 11, 2016
Sponsor
University of Ulm
Collaborators
RWTH Aachen University, Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT01837082
Brief Title
Iron in Congestive Heart Failure
Acronym
iCHF
Official Title
Randomized, Double-blind, Placebo-controlled Trial of Ferric Carboxymaltose Versus Placebo in Patients With Congestive Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
Collaborators
RWTH Aachen University, Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Iron Deficiency, Anemia
Keywords
Heart Failure, Iron Deficiency, Anemia, Ferric Carboxymaltose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iron
Arm Type
Active Comparator
Arm Description
ferric carboxymaltose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sodium chloride 0.9%
Intervention Type
Drug
Intervention Name(s)
ferric carboxymaltose
Other Intervention Name(s)
Ferinject
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sodium chloride 0.9%
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahir Karakas, MD
Organizational Affiliation
University of Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
University Heart Center Hamburg
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
University of Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany

12. IPD Sharing Statement

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Iron in Congestive Heart Failure

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