This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in patients with iron deficiency. Analyses will focus both on subjective and objective measures. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
456
Ferinject® will be administered in doses of 200 mg (4 mL) weekly up to iron repletion (correction phase of variable duration depending on individual iron deficit). The calculated dose will be rounded to the next 100 mg iron, i.e. the final dose may be 100 mg iron depending on the individual iron deficit. After the correction phase, Ferinject® will be given monthly in doses of 200 mg until the 24th week (maintenance phase).
During the correction phase, patients will receive the number of normal saline injections (4 mL weekly) corresponding to the calculated total iron dose needed according to the individual iron deficit. During the maintenance phase, placebo patients will receive 4 mL normal saline monthly.
Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy
Time frame: 24 weeks
Key secondary objectives (efficacy): Exercise tolerance (6-minute walk test distance). Further secondary objectives(efficacy): Health related quality of life, resource use and costs associated with the treatment, safety and tolerability
Time frame: 24 weeks
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Research Sites
Buenos Aires, Argentina
Research Site
Bad Nauheim, Germany
Research Site
Berlin, Germany
Research Site
Göttingen, Germany
Research Site
Hanover, Germany
Research Sites
Heidelberg, Germany
Research Site
Herford, Germany
Research Site
Herne, Germany
Research Site
Kiel, Germany
Research Site
München, Germany
...and 38 more locations