Status:
COMPLETED
A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency
Lead Sponsor:
Vifor Pharma
Collaborating Sponsors:
ICON Clinical Research
Conditions:
Iron Deficiency
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 fa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT01453608
Start Date
October 1 2011
End Date
January 1 2015
Last Update
March 18 2015
Active Locations (2)
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1
Clinical Military Hospital
Wroclaw, Poland, 50-891
2
State Educational Institution of Higer Professional Education
Ryazan, Russia, 390039