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      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

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          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 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.

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          Most cited references33

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          Controlling the False Discovery Rate: A Practical and Powerful Approach to Multiple Testing

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            ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the diagnosis and treatment of acute and chronic heart failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM).

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              Effect of intravenous iron sucrose on exercise tolerance in anemic and nonanemic patients with symptomatic chronic heart failure and iron deficiency FERRIC-HF: a randomized, controlled, observer-blinded trial.

              We tested the hypothesis that intravenous iron improves exercise tolerance in anemic and nonanemic patients with symptomatic chronic heart failure (CHF) and iron deficiency. Anemia is common in heart failure. Iron metabolism is disturbed, and administration of iron might improve both symptoms and exercise tolerance. We randomized 35 patients with CHF (age 64 +/- 13 years, peak oxygen consumption [pVO2] 14.0 +/- 2.7 ml/kg/min) to 16 weeks of intravenous iron (200 mg weekly until ferritin >500 ng/ml, 200 mg monthly thereafter) or no treatment in a 2:1 ratio. Ferritin was required to be <100 ng/ml or ferritin 100 to 300 ng/ml with transferrin saturation <20%. Patients were stratified according to hemoglobin levels (<12.5 g/dl [anemic group] vs. 12.5 to 14.5 g/dl [nonanemic group]). The observer-blinded primary end point was the change in absolute pVO2. The difference (95% confidence interval [CI]) in the mean changes from baseline to end of study between the iron and control groups was 273 (151 to 396) ng/ml for ferritin (p < 0.0001), 0.1 (-0.8 to 0.9) g/dl for hemoglobin (p = 0.9), 96 (-12 to 205) ml/min for absolute pVO2 (p = 0.08), 2.2 (0.5 to 4.0) ml/kg/min for pVO2/kg (p = 0.01), 60 (-6 to 126) s for treadmill exercise duration (p = 0.08), -0.6 (-0.9 to -0.2) for New York Heart Association (NYHA) functional class (p = 0.007), and 1.7 (0.7 to 2.6) for patient global assessment (p = 0.002). In anemic patients (n = 18), the difference (95% CI) was 204 (31 to 378) ml/min for absolute pVO2 (p = 0.02), and 3.9 (1.1 to 6.8) ml/kg/min for pVO2/kg (p = 0.01). In nonanemic patients, NYHA functional class improved (p = 0.06). Adverse events were similar. Intravenous iron loading improved exercise capacity and symptoms in patients with CHF and evidence of abnormal iron metabolism. Benefits were more evident in anemic patients. (Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure; http://www.clinicaltrials.gov/ct/show/NCT00125996; NCT00125996).
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                Author and article information

                Journal
                Eur J Heart Fail
                eurjhf
                eurjhf
                European Journal of Heart Failure
                Oxford University Press
                1388-9842
                1879-0844
                November 2009
                November 2009
                : 11
                : 11
                : 1084-1091
                Affiliations
                [1 ]Applied Cachexia Research, Department of Cardiology, simpleCharité, Campus Virchow-Klinikum , Augustenburger Platz 1, Berlin D-13353, Germany
                [2 ]Centre for Clinical and Basic Research, simpleIRCCS San Raffaele , Rome, Italy
                [3 ]simpleDepartment of Cardiology, Hospital del Mar (IMAS) , Barcelona, Spain
                [4 ]simpleDepartment of Medicine, Universitat Autonoma de Barcelona , Barcelona, Spain
                [5 ]simpleAthens University Hospital Attikon , Athens, Greece
                [6 ]simpleHeart Health Group , Malmö, Sweden
                [7 ]simpleLund University , Malmö, Sweden
                [8 ]simpleStavanger University Hospital , Stavanger, Norway
                [9 ]simpleUniversity of Bergen , Bergen, Norway
                [10 ]simpleMedizinische Hochschule Hannover , Hannover, Germany
                [11 ]Cardiology, Cardiovascular Center, simpleUniversity Hospital Zürich , Switzerland
                [12 ]simpleVifor Pharma Ltd , Glattbrugg, Switzerland
                [13 ]simpleLondon School of Hygiene and Tropical Medicine , London, UK
                [14 ]simpleNational Heart and Lung Institute, Imperial College , London, UK
                [15 ]simpleMedical University , Wroclaw, Poland
                Author notes
                [* ]Corresponding author. Tel: +49 30 450 553 463, Fax: +49 30 450 553 951, Email: s.anker@ 123456cachexia.de
                [†]

                Deceased.

                [‡]

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

                Article
                hfp140
                10.1093/eurjhf/hfp140
                2770581
                19875408
                2c86d4bc-4738-412e-99bd-dc2616b69ccd
                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

                History
                : 7 September 2009
                : 14 September 2009
                Categories
                Clinical Trials

                Cardiovascular Medicine
                ferric carboxymaltose,anaemia,treatment,iron deficiency,chronic heart failure

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