Chronic Heart Failure, Iron Deficiency
Conditions
Brief summary
The purpose of this study is to confirm that treatment with IV ferric carboxymaltose improves exercise capacity, physical functioning and quality of life in patients with iron deficiency and chronic heart failure.
Interventions
Subjects will receive ferric carboxymaltose intravenously on Day 0, Week 6, and Week 12
OTHERStandard of Care
Subjects randomised to Standard of Care may receive oral iron at Investigator's discretion however patients will not be permitted to receive IV iron
Sponsors
Vifor Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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 exercise capacity * Reduced left ventricular ejection fraction * 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 * No other significant cardiac or general disorder that would compromise participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Peak VO2 (mL/kg/min) from baseline to Week 24 | Week 24 |
Countries
Netherlands
Outcome results
None listed