This study is designed to assess, relative to placebo, the effects on the evolution of exercise capacity and symptomatic status of the addition of iron treatment with FCM (ferric carboxymaltose) to the basic regimen of ambulatory patients with stable symptomatic chronic CHF (congestive heart failure) and iron deficiency.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
35
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.
The distance covered in six-minute walk tests performed at 4, 12 and 24 weeks
Time frame: 24 weeks
NYHA class assessed at weeks 4, 12 and 24 after the start of study treatment
Time frame: 24 weeks
Cardiac function assessed by 2D Echo/Doppler cardiography
Time frame: 24 weeks
Self-reported patient global assessment of treatment
Time frame: 24 weeks
QOL as assessed by the European Quality of Life - 5 Dimensions and Kansas City Cardi
Time frame: 24 weeks
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Research Site
Copenhagen S, Denmark
Research Site
Esbjerg, Denmark
Research Site
Fredericia, Denmark
Research Site
Glostrup Municipality, Denmark
Research Site
Hellerup, Denmark
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Herning, Denmark
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Hilleroed, Denmark
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Svendborg, Denmark
Research Site
Boulogne, France
Research Site
Dijon, France
...and 31 more locations