PMID- 19875408
OWN - NLM
STAT- MEDLINE
DCOM- 20100325
LR  - 20211020
IS  - 1879-0844 (Electronic)
IS  - 1388-9842 (Print)
IS  - 1388-9842 (Linking)
VI  - 11
IP  - 11
DP  - 2009 Nov
TI  - 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.
PG  - 1084-91
LID - 10.1093/eurjhf/hfp140 [doi]
AB  - AIMS: Iron deficiency (ID) and anaemia are common in patients with chronic heart 
      failure (CHF). The presence of anaemia is associated with increased morbidity and 
      mortality in CHF, and ID is a major reason for the development of anaemia. 
      Preliminary studies using intravenous (i.v.) iron supplementation alone in 
      patients with CHF and ID have shown improvements in symptom status. FAIR-HF 
      (Clinical Trials.gov NCT00520780) was designed to determine the effect of i.v. 
      iron repletion therapy using ferric carboxymaltose on self-reported patient 
      global assessment (PGA) and New York Heart Association (NYHA) in patients with 
      CHF and ID. METHODS AND RESULTS: This is a multi-centre, randomized, 
      double-blind, placebo-controlled study recruiting ambulatory patients with 
      symptomatic CHF with LVEF < or = 40% (NYHA II) or < or =45% (NYHA III), ID 
      [ferritin <100 ng/mL or ferritin 100-300 ng/mL when transferrin saturation (TSAT) 
      < 20%], and haemoglobin 9.5-13.5 g/dL. Patients were randomized in a 2:1 ratio to 
      receive ferric carboxymaltose (Ferinject((R))) 200 mg iron i.v. or saline i.v. 
      weekly until iron repletion (correction phase), then monthly until Week 24 
      (maintenance phase). Primary endpoints are (i) self-reported PGA at Week 24 and 
      (ii) NYHA class at Week 24, adjusted for baseline NYHA class. CONCLUSION: This 
      study will provide evidence on the efficacy and safety of iron repletion with 
      ferric carboxymaltose in CHF patients with ID with and without anaemia.
FAU - Anker, Stefan D
AU  - Anker SD
AD  - Department of Cardiology, Charite, Campus Virchow-Klinikum, Augustenburger Platz 
      1, Berlin D-13353, Germany.
FAU - Colet, Josep Comin
AU  - Colet JC
FAU - Filippatos, Gerasimos
AU  - Filippatos G
FAU - Willenheimer, Ronnie
AU  - Willenheimer R
FAU - Dickstein, Kenneth
AU  - Dickstein K
FAU - Drexler, Helmut
AU  - Drexler H
FAU - Luscher, Thomas F
AU  - Luscher TF
FAU - Mori, Claudio
AU  - Mori C
FAU - von Eisenhart Rothe, Barbara
AU  - von Eisenhart Rothe B
FAU - Pocock, Stuart
AU  - Pocock S
FAU - Poole-Wilson, Philip A
AU  - Poole-Wilson PA
FAU - Ponikowski, Piotr
AU  - Ponikowski P
CN  - FAIR-HF committees and investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00520780
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
RN  - 0 (Ferric Compounds)
RN  - 6897GXD6OE (ferric carboxymaltose)
RN  - 69-79-4 (Maltose)
SB  - IM
MH  - Algorithms
MH  - Anemia, Iron-Deficiency/*drug therapy/physiopathology
MH  - Chronic Disease
MH  - Clinical Protocols
MH  - Double-Blind Method
MH  - Female
MH  - Ferric Compounds/*administration & dosage
MH  - Heart Failure/complications/*drug therapy
MH  - Humans
MH  - Injections, Intravenous
MH  - Male
MH  - Maltose/administration & dosage/*analogs & derivatives
MH  - Patient Care/*methods
MH  - Reference Values
MH  - Research Design
MH  - Treatment Outcome
PMC - PMC2770581
EDAT- 2009/10/31 06:00
MHDA- 2010/03/26 06:00
PMCR- 2009/11/01
CRDT- 2009/10/31 06:00
PHST- 2009/10/31 06:00 [entrez]
PHST- 2009/10/31 06:00 [pubmed]
PHST- 2010/03/26 06:00 [medline]
PHST- 2009/11/01 00:00 [pmc-release]
AID - hfp140 [pii]
AID - 10.1093/eurjhf/hfp140 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2009 Nov;11(11):1084-91. doi: 10.1093/eurjhf/hfp140.