Iron in Congestive Heart Failure

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01837082

Acronym

iCHF

Enrollment

Registered

2013-04-22

Start date

2013-04-30

Completion date

2015-12-31

Last updated

2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Heart Failure, Iron Deficiency

Keywords

Heart Failure, Iron Deficiency, Anemia, Ferric Carboxymaltose

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.

Interventions

DRUGferric carboxymaltose

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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.	12 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026