Iron in Congestive Heart Failure

Heart Failure Clinical Trial

— iCHF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01837082
• Other study ID #: iCHF_D.3874
• Secondary ID: 2012-001134-33
• Status: Terminated
• Phase: Phase 3
• First received: April 17, 2013
• Last updated: May 11, 2016
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Heart Failure
• Iron Deficiency

Intervention

Drug:
• ferric carboxymaltose

• Placebo

Locations

Country	Name	City	State
Germany	University of Aachen	Aachen
Germany	University Heart Center Hamburg	Hamburg
Germany	University of Ulm	Ulm

Sponsors (3)

Lead Sponsor	Collaborator
University of Ulm	RWTH Aachen University, Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No