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

Stefan D. Anker, Josep Comin Colet, Gerasimos Filippatos, Ronnie Willenheimer, Kenneth Dickstein, Helmut Drexler, Thomas F. Lüscher, Claudio Mori, Barbara Von Eisenhart Rothe, Stuart Pocock, Philip A. Poole-Wilson, Piotr Ponikowski

Research output: Contribution to journalArticlepeer-review

Abstract

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 resultsThis 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 ®) 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.ConclusionThis study will provide evidence on the efficacy and safety of iron repletion with ferric carboxymaltose in CHF patients with ID with and without anaemia.

Original languageEnglish
Pages (from-to)1084-1091
Number of pages8
JournalEuropean Journal of Heart Failure
Volume11
Issue number11
DOIs
Publication statusPublished - Nov 2009

Keywords

  • Anaemia
  • Chronic heart failure
  • Ferric carboxymaltose
  • Iron deficiency
  • Treatment

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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