Chronic Heart Failure, Iron Deficiency
Conditions
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 failure and iron deficiency.
Interventions
Subjects will receive Ferinject (ferric carboxymaltose) intravenously on Day 0
DRUGPlacebo (saline)
Subjects will receive Placebo (saline) intravenously on Day 0
Sponsors
ICON Clinical Research
Vifor Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in six minute walk test from baseline to week 24 | 24 weeks |
Countries
Poland, Russia
Outcome results
None listed