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.
Drug: Ferinject (ferric carboxymaltose)
Drug: Placebo (saline)
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Full eligibility criteria for NCT01453608
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
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
All locations for NCT01453608
Clinical Military Hospital
Wroclaw, Poland, 50-891
Russian Federation (1)
State Educational Institution of Higer Professional Education
Ryazan, Russian Federation, 390039
View full eligibility
Tris trial is registered with FDA with number: NCT01453608. The sponsor of the trial is Vifor Inc. and it is looking for 304 volunteers for the current phase.
Official trial title: 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
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