Iron in Congestive Heart Failure (iCHF)

University of Ulm

Status and phase: Terminated; Phase 3

Conditions: Anemia; Iron Deficiency; Heart Failure

Treatments: Drug: Placebo; Drug: ferric carboxymaltose

Study type: Interventional

Funder types: Other

Identifiers

NCT01837082

2012-001134-33 (EudraCT Number)

iCHF_D.3874

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

Iron

Active Comparator group

Description:

ferric carboxymaltose

Treatment:

Drug: ferric carboxymaltose

Placebo

Placebo Comparator group

Description:

Sodium chloride 0.9%

Treatment:

Drug: Placebo