Ferinject® Assessment in Patients With Iron Deficiency and Chronic Heart Failure (FAIR-HF)
FAIR-HF
A Randomised Double-blind Controlled Phase III Study to Compare the Efficacy and Safety of Intravenous Iron Carboxymaltose (Ferinject®) With Placebo in Patients With Chronic Heart Failure and Iron Deficiency
1 other identifier
interventional
456
10 countries
48
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2007
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 24, 2007
CompletedFirst Posted
Study publicly available on registry
August 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedOctober 14, 2021
March 1, 2010
2.3 years
August 24, 2007
October 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy
24 weeks
Secondary Outcomes (1)
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
24 weeks
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF)
- 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%
You may not qualify if:
- History of acquired iron overload.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vifor Pharmalead
- Syneos Healthcollaborator
- ClinStar, LLCcollaborator
Study Sites (48)
Research Sites
Buenos Aires, Argentina
Research Site
Bad Nauheim, Germany
Research Site
Berlin, Germany
Research Site
Göttingen, Germany
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Hanover, Germany
Research Sites
Heidelberg, Germany
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Herford, Germany
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Herne, Germany
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Kiel, Germany
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München, Germany
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Athens, Greece
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Heraklion, Greece
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Ascoli Piceno, Italy
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Pavia, Italy
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Rome, Italy
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Vicenza, Italy
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Stavanger, Norway
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Bialystok, Poland
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Krakow, Poland
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Opole, Poland
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Piotrkow Trybunalski, Poland
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Siedlce, Poland
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Torun, Poland
Research Sites
Warsaw, Poland
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Wałbrzych, Poland
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Wroclaw, Poland
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Włocławek, Poland
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Zabrze, Poland
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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
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Bilbao, Spain
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Madrid, Spain
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Valencia, Spain
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
Research Sites
Kiev, Ukraine
Research Site
Lviv, Ukraine
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Mykolayiv, Ukraine
Research Site
Odesa, Ukraine
Research Site
Zaporizhzhya, Ukraine
Related Publications (2)
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.
PMID: 19920054DERIVEDAnker 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.
PMID: 19875408DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip A Poole-Wilson, MD FRCP
National Heart and Lung Institute. Faculty of Medicine. Imperial College London. Dovehouse Street, London SW3 6LY, UK
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2007
First Posted
August 27, 2007
Study Start
April 1, 2007
Primary Completion
July 1, 2009
Study Completion
September 1, 2009
Last Updated
October 14, 2021
Record last verified: 2010-03