Ferinject® Assessment in Patients With IRon Deficiency and Chronic Heart Failure (FAIR-HF) (FAIR-HF)
|Chronic Heart Failure Iron Deficiency Iron Deficiency Anemia Anaemia||Drug: Ferinject ® (Ferric carboxymaltose) Drug: Normal saline (0.9%)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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|
- 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 ]
|Study Start Date:||April 2007|
|Study Completion Date:||September 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520780
Show 48 Study Locations
|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|