Ferinject® Assessment in Patients With Iron Deficiency and Chronic Heart Failure (FAIR-HF)
NCT ID: NCT00520780
Last Updated: 2021-10-14
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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COMPLETED
PHASE3
456 participants
INTERVENTIONAL
2007-04-30
2009-09-30
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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Syneos Health
OTHER
ClinStar, LLC
INDUSTRY
Vifor Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Philip A Poole-Wilson, MD FRCP
Role: PRINCIPAL_INVESTIGATOR
National Heart and Lung Institute. Faculty of Medicine. Imperial College London. Dovehouse Street, London SW3 6LY, UK
Locations
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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
Research Site
Athens, , Greece
Research Site
Heraklion, , Greece
Research Site
Ascoli Piceno, , Italy
Research Site
Pavia, , Italy
Research Site
Rome, , Italy
Research Site
Vicenza, , Italy
Research Site
Stavanger, , Norway
Research Site
Bialystok, , Poland
Research Site
Krakow, , Poland
Research Site
Opole, , Poland
Research Site
Piotrkow Trybunalski, , Poland
Research Site
Siedlce, , Poland
Research Site
Torun, , Poland
Research Sites
Warsaw, , Poland
Research Site
Wałbrzych, , Poland
Research Site
Wroclaw, , Poland
Research Site
Włocławek, , Poland
Research Site
Zabrze, , Poland
Research Site
Brasov, , Romania
Research Sites
Bucharest, , Romania
Reserach Site
Craiova, , Romania
Research Sites
Târgu Mureş, , Romania
Reserach Sites
Moscow, , Russia
Resarch Sites
Saint Petersburg, , Russia
Research Sites
Veliky Novgorod, , Russia
Research Site
Alicante, , Spain
Research Sites
Barcelona, , Spain
Research Site
Bilbao, , Spain
Research Site
Madrid, , Spain
Research Site
Valencia, , Spain
Research Site
Dnipropetrovsk, , Ukraine
Research Site
Donetsk, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Sites
Kiev, , Ukraine
Research Site
Lviv, , Ukraine
Research Site
Mykolayiv, , Ukraine
Research Site
Odesa, , Ukraine
Research Site
Zaporizhzhya, , Ukraine
Countries
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References
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Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart Rothe B, Pocock SJ, Poole-Wilson PA, Ponikowski P; FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.
Anker SD, Colet JC, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Mori C, von Eisenhart Rothe B, Pocock S, Poole-Wilson PA, Ponikowski P; FAIR-HF committees and investigators. Rationale and design of Ferinject assessment in patients with IRon deficiency and chronic Heart Failure (FAIR-HF) study: a randomized, placebo-controlled study of intravenous iron supplementation in patients with and without anaemia. Eur J Heart Fail. 2009 Nov;11(11):1084-91. doi: 10.1093/eurjhf/hfp140.
Other Identifiers
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FER-CARS-02
Identifier Type: -
Identifier Source: org_study_id