Skip Navigation

European Journal of Heart Failure 2009 11(11):1084-1091; doi:10.1093/eurjhf/hfp140
This Article
Right arrow Full Text Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow Supplementary Data
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Anker, S. D.
PubMed
Right arrow PubMed Citation
Right arrow Articles by Anker, S. D.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2009. For permissions please email: journals.permissions@oxfordjournals.org.
The online version of this article has been published under an open access model. Users are entitled to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that the original authorship is properly and fully attributed; the Journal, Learned Society and Oxford University Press are attributed as the original place of publication with correct citation details given; if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative work this must be clearly indicated. For commercial re-use, please contact journals.permissions@oxfordjournals.org

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. Anker1,2,*, Josep Comin Colet3,4, Gerasimos Filippatos5, Ronnie Willenheimer6,7, Kenneth Dickstein8,9, Helmut Drexler10,{dagger}, Thomas F. Lüscher11, Claudio Mori12, Barbara von Eisenhart Rothe12, Stuart Pocock13, Philip A. Poole-Wilson14,{dagger}, Piotr Ponikowski15 and on behalf of the FAIR-HF committees and investigators{ddagger}

1 Applied Cachexia Research, Department of Cardiology, Charité, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin D-13353, Germany
2 Centre for Clinical and Basic Research, IRCCS San Raffaele, Rome, Italy
3 Department of Cardiology, Hospital del Mar (IMAS), Barcelona, Spain
4 Department of Medicine, Universitat Autonoma de Barcelona, Barcelona, Spain
5 Athens University Hospital Attikon, Athens, Greece
6 Heart Health Group, Malmö, Sweden
7 Lund University, Malmö, Sweden
8 Stavanger University Hospital, Stavanger, Norway
9 University of Bergen, Bergen, Norway
10 Medizinische Hochschule Hannover, Hannover, Germany
11 Cardiology, Cardiovascular Center, University Hospital Zürich, Switzerland
12 Vifor Pharma Ltd, Glattbrugg, Switzerland
13 London School of Hygiene and Tropical Medicine, London, UK
14 National Heart and Lung Institute, Imperial College, London, UK
15 Medical University, Wroclaw, Poland

* Corresponding author. Tel: +49 30 450 553 463, Fax: +49 30 450 553 951, Email: s.anker{at}cachexia.de


  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 [ClinicalTrials.gov] ) 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 ≤ 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®) 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.

Key Words: Chronic heart failure • Iron deficiency • Anaemia • Treatment • Ferric carboxymaltose

Received September 7, 2009; Revised September 14, 2009;

{dagger} Deceased.

{ddagger} FAIR-HF committees are listed in the Study Committees section. A full list of investigators is available in Supplementary material online.


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 NEJMHome page
S. D. Anker, J. Comin Colet, G. Filippatos, R. Willenheimer, K. Dickstein, H. Drexler, T. F. Luscher, B. Bart, W. Banasiak, J. Niegowska, et al.
Ferric Carboxymaltose in Patients with Heart Failure and Iron Deficiency
N. Engl. J. Med., November 17, 2009; (2009) NEJMoa0908355v1.
[Abstract] [Full Text] [PDF]


Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.