Τίτλος:
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
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Συγγραφείς:
Anker, Stefan D.
Colet, Josep Comin
Filippatos, Gerasimos and
Willenheimer, Ronnie
Dickstein, Kenneth
Drexler, Helmut and
Luescher, Thomas F.
Mori, Claudio
Rothe, Barbara von Eisenhart
and Pocock, Stuart
Poole-Wilson, Philip A.
Ponikowski, Piotr and
FAIR-HF Comm & Investigators
Περιοδικό:
European Journal of Heart Failure
Λέξεις-κλειδιά:
Chronic heart failure; Iron deficiency; Anaemia; Treatment; Ferric
carboxymaltose
DOI:
10.1093/eurjhf/hfp140
