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Ferinject® Assessment in Patients With Iron Deficiency and Chronic Heart Failure (FAIR-HF) (FAIR-HF)

Primary Purpose

Chronic Heart Failure, Iron Deficiency, Iron Deficiency Anemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ferinject ® (Ferric carboxymaltose)
Normal saline (0.9%)
Sponsored by
Vifor Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic Heart Failure, Iron deficiency, Iron deficiency anaemia, Anaemia, Heart disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy

Secondary Outcome Measures

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

Full Information

First Posted
August 24, 2007
Last Updated
October 5, 2021
Sponsor
Vifor Pharma
Collaborators
Syneos Health, ClinStar, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00520780
Brief Title
Ferinject® Assessment in Patients With Iron Deficiency and Chronic Heart Failure (FAIR-HF)
Acronym
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

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vifor Pharma
Collaborators
Syneos Health, ClinStar, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Iron Deficiency, Iron Deficiency Anemia, Anaemia
Keywords
Chronic Heart Failure, Iron deficiency, Iron deficiency anaemia, Anaemia, Heart disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
456 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ferinject ® (Ferric carboxymaltose)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Normal saline (0.9%)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip A Poole-Wilson, MD FRCP
Organizational Affiliation
National Heart and Lung Institute. Faculty of Medicine. Imperial College London. Dovehouse Street, London SW3 6LY, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Sites
City
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Bad Nauheim
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Göttingen
Country
Germany
Facility Name
Research Site
City
Hannover
Country
Germany
Facility Name
Research Sites
City
Heidelberg
Country
Germany
Facility Name
Research Site
City
Herford
Country
Germany
Facility Name
Research Site
City
Herne
Country
Germany
Facility Name
Research Site
City
Kiel
Country
Germany
Facility Name
Research Site
City
München
Country
Germany
Facility Name
Research Site
City
Athens
Country
Greece
Facility Name
Research Site
City
Heraklion
Country
Greece
Facility Name
Research Site
City
Ascoli Piceno
Country
Italy
Facility Name
Research Site
City
Pavia
Country
Italy
Facility Name
Research Site
City
Rome
Country
Italy
Facility Name
Research Site
City
Vicenza
Country
Italy
Facility Name
Research Site
City
Stavanger
Country
Norway
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Opole
Country
Poland
Facility Name
Research Site
City
Piotrkow Trybunalski
Country
Poland
Facility Name
Research Site
City
Siedlce
Country
Poland
Facility Name
Research Site
City
Torun
Country
Poland
Facility Name
Research Site
City
Walbrzych
Country
Poland
Facility Name
Research Sites
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Wloclawek
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Zabrze
Country
Poland
Facility Name
Research Site
City
Brasov
Country
Romania
Facility Name
Research Sites
City
Bucharest
Country
Romania
Facility Name
Reserach Site
City
Craiova
Country
Romania
Facility Name
Research Sites
City
Targu Mures
Country
Romania
Facility Name
Reserach Sites
City
Moscow
Country
Russian Federation
Facility Name
Research Sites
City
Novgorod
Country
Russian Federation
Facility Name
Resarch Sites
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Alicante
Country
Spain
Facility Name
Research Sites
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Bilbao
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Research Site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Research Site
City
Donetsk
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
Country
Ukraine
Facility Name
Research Sites
City
Kiev
Country
Ukraine
Facility Name
Research Site
City
Lviv
Country
Ukraine
Facility Name
Research Site
City
Mykolayiv
Country
Ukraine
Facility Name
Research Site
City
Odessa
Country
Ukraine
Facility Name
Research Site
City
Zaporozhye
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
19920054
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.
Results Reference
derived
PubMed Identifier
19875408
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.
Results Reference
derived

Learn more about this trial

Ferinject® Assessment in Patients With Iron Deficiency and Chronic Heart Failure (FAIR-HF)

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