EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure
NCT ID: NCT00821717
Last Updated: 2015-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
35 participants
INTERVENTIONAL
2008-12-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1:
Ferinject ® (Ferric carboxymaltose)
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).
2
Normal saline (0.9%)
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.
Interventions
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Ferinject ® (Ferric carboxymaltose)
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).
Normal saline (0.9%)
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.
Eligibility Criteria
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Inclusion Criteria
* Left ventricular ejection fraction (LVEF) 40% or lower for patients in NYHA II and 45% or lower in NYHA III
* Screening haemoglobin (Hb) at least 9.5 g/dL but below or equal to 13.5 g/dL (average of 2 haemoglobin concentrations)
* Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%
Exclusion Criteria
* Known active infection, clinically significant bleeding, active malignancy.
* Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST)
* Anaemia due to reasons other than iron deficiency
* Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
* History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.
* Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.
* Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months.
* Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.
18 Years
ALL
No
Sponsors
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Socar Research SA
NETWORK
Vifor Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Motro, MD, FACC
Role: STUDY_CHAIR
Sheba Medical Center, Tel-Hashomer 52621, Israel
Locations
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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
Research Site
Herning, , Denmark
Research Site
Hilleroed, , Denmark
Research Site
Svendborg, , Denmark
Research Site
Boulogne, , France
Research Site
Dijon, , France
Research Site
Lyon, , France
Research Site
Montpellier, , France
Research Site
Nantes, , France
Research Site
Pontoise, , France
Research Site
Rennes, , France
Research Site
Saintes, , France
Research Site
Strasbourg, , France
Research Site
Cologne, , Germany
Research Site
Düren, , Germany
Research Site
Frankfurt, , Germany
Research Site
Homburg/Saar, , Germany
Research Site
Mainz, , Germany
Research Site
Würzburg, , Germany
Research Site
Afula, , Israel
Research Site
Ashkelon, , Israel
Research Site
Haifa, , Israel
Research Site
Holon, , Israel
Research Site
Jerusalem, , Israel
Research Site
Kfar Saba, , Israel
Research Site
Rehovot, , Israel
Research Site
Safed, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Tel Litwinsky, , Israel
Research Site
's-Hertogenbosch, , Netherlands
Research Site
Amsterdam, , Netherlands
Research Site
Eindhoven, , Netherlands
Research Site
Heerenveen, , Netherlands
Research Site
Leiden, , Netherlands
Research Site
Nieuwegein, , Netherlands
Research Site
Tilburg, , Netherlands
Research Site
Utrecht, , Netherlands
Countries
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Other Identifiers
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FER-CARS-03
Identifier Type: -
Identifier Source: org_study_id
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