Trial | NCT01453608  Report issue

Title

A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency
A Randomised, Double-blind Controlled Phase 4 Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    304
The purpose of this study is to determine, relative to placebo, the effect of iron repletion therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with chronic heart failure and iron deficiency.
Study Started
Oct 31
2011
Primary Completion
Feb 28
2014
Study Completion
Jan 31
2015
Last Update
Mar 18
2015
Estimate

Drug Ferinject (ferric carboxymaltose)

Subjects will receive Ferinject (ferric carboxymaltose) intravenously on Day 0

Drug Placebo (saline)

Subjects will receive Placebo (saline) intravenously on Day 0

Ferinject (ferric carboxymaltose) Experimental

Placebo (saline) Placebo Comparator

Criteria 

Inclusion Criteria:

Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
Reduced left ventricular ejection fraction
Capable of completing 6 minute walk test
At least 18 years of age and with written informed consent prior to any study specific procedures

Exclusion Criteria:

Erythropoietin stimulating agent (ESA) use, IV iron therapy and/or blood transfusion in previous 6 weeks prior to randomisation
Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
Chronic liver disease and/or elevated liver enzymes
Vitamin B12 and/or serum folate deficiency
Subject is not using adequate contraceptive precautions during the study
Body weight ≤ 35 kg
No other significant cardiac or general disorders that would compromise the ability to give informed consent and/or comply with study procedures
No Results Posted