Clinical trial NCT00520780: Ferinject® Assessment in Patients With Iron Deficiency and Chronic Heart Failure (FAIR-HF)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Heart Failure
Iron Deficiency
Iron Deficiency Anemia
Anaemia
Keywords: Chronic Heart Failure
Iron deficiency
Iron deficiency anaemia
Anaemia
Heart disease
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
name: ClinStar, LLC
First posted: 2007-08-27
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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%

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy
timeFrame: 24 weeks
Secondary outcomes:
measure: 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
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Research Sites
city: Bad Nauheim
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Göttingen
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Sites
city: Herford
country: Germany
facility: Research Site
city: Herne
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Heraklion
country: Greece
facility: Research Site
city: Ascoli Piceno
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Vicenza
country: Italy
facility: Research Site
city: Stavanger
country: Norway
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Opole
country: Poland
facility: Research Site
city: Piotrkow Trybunalski
country: Poland
facility: Research Site
city: Siedlce
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Walbrzych
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Sites
city: Wloclawek
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Sites
city: Craiova
country: Romania
facility: Reserach Site
city: Targu Mures
country: Romania
facility: Research Sites
city: Moscow
country: Russian Federation
facility: Reserach Sites
city: Novgorod
country: Russian Federation
facility: Research Sites
city: St. Petersburg
country: Russian Federation
facility: Resarch Sites
city: Alicante
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Sites
city: Bilbao
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Sites
city: Lviv
country: Ukraine
facility: Research Site
city: Mykolayiv
country: Ukraine
facility: Research Site
city: Odessa
country: Ukraine
facility: Research Site
city: Zaporozhye
country: Ukraine
facility: Research Site
Study officials:
affiliation: National Heart and Lung Institute. Faculty of Medicine. Imperial College London. Dovehouse Street, London SW3 6LY, UK
name: Philip A Poole-Wilson, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.