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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00520780
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : October 16, 2009
Syneos Health
ClinStar, LLC
Information provided by:
Vifor Pharma

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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Iron Deficiency Iron Deficiency Anemia Anaemia Drug: Ferinject ® (Ferric carboxymaltose) Drug: Normal saline (0.9%) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron

Arm Intervention/treatment
Experimental: 1 Drug: 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).

Placebo Comparator: 2 Drug: 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.

Primary Outcome Measures :
  1. Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  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 [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00520780

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Sponsors and Collaborators
Vifor Pharma
Syneos Health
ClinStar, LLC
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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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00520780    
Other Study ID Numbers: FER-CARS-02
First Posted: August 27, 2007    Key Record Dates
Last Update Posted: October 16, 2009
Last Verified: October 2009
Keywords provided by Vifor Pharma:
Chronic Heart Failure
Iron deficiency
Iron deficiency anaemia
Heart disease
Additional relevant MeSH terms:
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Heart Failure
Anemia, Iron-Deficiency
Heart Diseases
Cardiovascular Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases