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

Research output: Contribution to journalArticle

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 < 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.

Details

Authors
  • Stefan D. Anker
  • Josep Comin Colet
  • Gerasimos Filippatos
  • Ronnie Willenheimer
  • Kenneth Dickstein
  • Helmut Drexler
  • Thomas F. Luescher
  • Claudio Mori
  • Barbara von Eisenhart Rothe
  • Stuart Pocock
  • Philip A. Poole-Wilson
  • Piotr Ponikowski
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cardiac and Cardiovascular Systems

Keywords

  • Ferric, Treatment, Anaemia, Chronic heart failure, Iron deficiency, carboxymaltose
Original languageEnglish
Pages (from-to)1084-1091
JournalEuropean Journal of Heart Failure
Volume11
Issue number11
Publication statusPublished - 2009
Publication categoryResearch
Peer-reviewedYes