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Rationale and design of Ferinject((R)) 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

Anker, Stefan D.; Colet, Josep Comin; Filippatos, Gerasimos; Willenheimer, Ronnie LU ; Dickstein, Kenneth; Drexler, Helmut; Luescher, Thomas F.; Mori, Claudio; Rothe, Barbara von Eisenhart and Pocock, Stuart, et al. (2009) In European Journal of Heart Failure 11(11). p.1084-1091
Abstract
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. This is a multi-centre, randomized, double-blind, placebo-controlled study recruiting ambulatory patients with... (More)
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. This is a multi-centre, randomized, double-blind, placebo-controlled study recruiting ambulatory patients with symptomatic CHF with LVEF < 40% (NYHA II) 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. 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. (Less)
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publication status
published
subject
keywords
Ferric, Treatment, Anaemia, Chronic heart failure, Iron deficiency, carboxymaltose
in
European Journal of Heart Failure
volume
11
issue
11
pages
1084 - 1091
publisher
Elsevier
external identifiers
  • wos:000271389000011
  • scopus:71049116042
ISSN
1879-0844
DOI
10.1093/eurjhf/hfp140
language
English
LU publication?
yes
id
13b85880-7d30-4a5e-9106-aa53825e9ce7 (old id 1505115)
date added to LUP
2009-11-24 16:32:51
date last changed
2017-11-05 03:46:49
@article{13b85880-7d30-4a5e-9106-aa53825e9ce7,
  abstract     = {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. This is a multi-centre, randomized, double-blind, placebo-controlled study recruiting ambulatory patients with symptomatic CHF with LVEF &lt; 40% (NYHA II) or &lt; 45% (NYHA III), ID [ferritin &lt; 100 ng/mL or ferritin 100-300 ng/mL when transferrin saturation (TSAT) &lt; 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. 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.},
  author       = {Anker, Stefan D. and Colet, Josep Comin and Filippatos, Gerasimos and Willenheimer, Ronnie and Dickstein, Kenneth and Drexler, Helmut and Luescher, Thomas F. and Mori, Claudio and Rothe, Barbara von Eisenhart and Pocock, Stuart and Poole-Wilson, Philip A. and Ponikowski, Piotr},
  issn         = {1879-0844},
  keyword      = {Ferric,Treatment,Anaemia,Chronic heart failure,Iron deficiency,carboxymaltose},
  language     = {eng},
  number       = {11},
  pages        = {1084--1091},
  publisher    = {Elsevier},
  series       = {European Journal of Heart Failure},
  title        = {Rationale and design of Ferinject((R)) 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},
  url          = {http://dx.doi.org/10.1093/eurjhf/hfp140},
  volume       = {11},
  year         = {2009},
}