Ferinject® Assessment in Patients With IRon Deficiency and Chronic Heart Failure (FAIR-HF) (FAIR-HF)
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|ClinicalTrials.gov Identifier: NCT00520780|
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : October 16, 2009
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||456 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy [ Time Frame: 24 weeks ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT00520780
|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|