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

European Journal of Heart Failure

Volumn 11, Issue 11, 2009, Pages 1084-1091

  Anker, Stefan D ^a,b   Colet, Josep Comin ^c,d   Filippatos, Gerasimos ^e   Willenheimer, Ronnie ^f,g   Dickstein, Kenneth ^h,i   Drexler, Helmut ^j   Lüscher, Thomas F ^k   Mori, Claudio ^l   Von Eisenhart Rothe, Barbara ^l   Pocock, Stuart ^m   Poole Wilson, Philip A ⁿ   Ponikowski, Piotr ^o  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b IRCCS SAN RAFFAELE PISANA   (Italy)

^c HOSPITAL DEL MAR   (Spain)

^d UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^e NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS   (Greece)

^f Heart Health Group   (Sweden)

^g LUND UNIVERSITY   (Sweden)

^h STAVANGER UNIVERSITY HOSPITAL   (Norway)

ⁱ UNIVERSITY OF BERGEN   (Norway)

^j HANNOVER MEDICAL SCHOOL   (Germany)

^k UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^l Vifor (International) Inc   (Switzerland)

^m LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

ⁿ NATIONAL HEART AND LUNG INSTITUTE   (United Kingdom)

^o WROCLAW MEDICAL UNIVERSITY   (Poland)

more..

Author keywords

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

Indexed keywords

FERINJECT; FERRIC CARBOXYMALTOSE; FERRITIN; HEMOGLOBIN; IRON DERIVATIVE; PLACEBO; SODIUM CHLORIDE; TRANSFERRIN; UNCLASSIFIED DRUG;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE ASSOCIATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FERRITIN BLOOD LEVEL; HEART FAILURE; HEART LEFT VENTRICLE FUNCTION; HUMAN; IRON DEFICIENCY; IRON DEFICIENCY ANEMIA; IRON THERAPY; MAJOR CLINICAL STUDY; MULTICENTER STUDY; PATIENT ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SYMPTOM; TREATMENT OUTCOME; UNITED STATES;

ALGORITHMS; ANEMIA, IRON-DEFICIENCY; CHRONIC DISEASE; CLINICAL PROTOCOLS; DOUBLE-BLIND METHOD; FEMALE; FERRIC COMPOUNDS; HEART FAILURE; HUMANS; INJECTIONS, INTRAVENOUS; MALE; MALTOSE; PATIENT CARE; REFERENCE VALUES; RESEARCH DESIGN; TREATMENT OUTCOME;

EID: 71049116042     PISSN: 13889842     EISSN: 18790844     Source Type: Journal    
DOI: 10.1093/eurjhf/hfp140     Document Type: Article

References (35)

1. Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Strömberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K. 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). Eur J Heart Fail 2008;10:933-989.
2. Roger VL, Weston SA, Redfield MM, Hellermann-Homan JP, Killian J, Yawn BP, Jacobsen SJ. Trends in heart failure incidence and survival in a community-based population. J Am Med Assoc 2004;292:344-350.
3. Berry C, Murdoch DR, McMurray JJ. Economics of chronic heart failure. Eur J Heart Fail 2001;3:283-291.
4. Pina IL, Apstein CS, Balady GJ, Belardinelli R, Chaitman BR, Duscha BD, Fletcher BJ, Fleg JL, Myers JN, Sullivan MJ, American Heart Association Committee on exercise, rehabilitation, prevention. Exercise and heart failure: a statement from the American Heart Association Committee on exercise, rehabilitation, and prevention. Circulation 2003;107:1210-1225.
5. Clark AL, Poole-Wilson PA, Coats AJS. Exercise limitation in chronic heart failure: central role of the periphery. J Am Coll Cardiol 1996;28:1092-1102.
6. Harrington D, Anker SD, Chua TP, Webb-Peploe K, Ponikowski P, Poole-Wilson PA, Coats AJ. Skeletal muscle function and its relation to exercise tolerance in chronic heart failure. J Am Coll Cardiol 1997;30:1758-1764.
7. Fairbanks V, Beutler E. Iron deficiency. In Beutler E (ed.), Williams Hematology. 6th ed. New York: McGraw-Hill; 2001. p295-304 and p.447-1440.
8. Dunn LL, Rahmanto YS, Richardson DR. Iron uptake and metabolism in the new millennium. Trends Cell Biol 2007;17:93-100.
9. Haas JD, Brownlie T IV. Iron deficiency and reduced work capacity: a critical review of the research to determine a causal relationship. J Nutr 2001;131: 676S-688S.
10. Dallman PR. Iron deficiency: does it matter? J Intern Med 1989;226:367-372.
11. Davies KJ, Maguire JJ, Brooks GA, Dallman PR, Packer L. Muscle mitochondrial bioenergetics, oxygen supply, and work capacity during dietary iron deficiency and repletion. Am J Physiol 1982;242:E418-E427.
12. Satija P, Ondo WG. Restless legs syndrome: pathophysiology, diagnosis and treatment. CNS Drugs 2008;22:497-518.
13. Lainscak M, von Haehling S, Anker SD. Natriuretic peptides and other biomarkers in chronic heart failure: from BNP, NT-proBNP, and MR-proANP to routine biochemical markers. Int J Cardiol 2009;132:303-311.
14. Tang WH, Tong W, Jain A, Francis GS, Harris CM, Young JB. Evaluation and long-term prognosis of new-onset, transient, and persistent anemia in ambulatory patients with chronic heart failure. J Am Coll Cardiol 2008;51:569-576.
15. Anand IS, Kuskowski MA, Rector TS, Florea VG, Glazer RD, Hester A, Chiang YT, Aknay N, Maggioni AP, Opasich C, Latini R, Cohn JN. Anemia and change in hemoglobin over time related to mortality and morbidity in patients with chronic heart failure: results from Val-HeFT. Circulation 2005;112:1121-1127.
16. Komajda M, Anker SD, Charlesworth A, Okonko D, Metra M, Di Lenarda A, Remme W, Moullet C, Swedberg K, Cleland JG, Poole-Wilson PA. The impact of new onset anaemia on morbidity and mortality in chronic heart failure: results from COMET. Eur Heart J 2006;27:1440-1446.
17. Szachniewicz J, Petruk-Kowalczyk J, Majda J, Kaczmarek A, Reczuch K, Kalra PR, Piepoli MF, Anker SD, Banasiak W, Ponikowski P. Anaemia is an independent predictor of poor outcome in patients with chronic heart failure. Int J Cardiol 2003;90:303-308.
18. Nordyke RJ, Kim JJ, Goldberg GA, Vendiola R, Batra D, McCamish M, Thomasson JW. Impact of anemia on hospitalization time, charges, and mortality in patients with heart failure. Value Health 2004;7:464-471.
19. Weiss G, Goodnough LT. Anemia of chronic disease. N Eng J Med 2005;352: 1011-1023.
20. Kemna EH, Tjalsma H, Willems HL, Swinkels DW. Hepcidin: from discovery to differential diagnosis. Haematologica 2008;93:90-97.
21. Crichton RR, Danielson BG, Geisser P. Iron Therapy with Special Emphasis on Intravenous Administration. 4th ed. London, Boston: International Medical Publishers; 2008.
22. Ganzoni AM. Intravenous iron-dextran: therapeutic and experimental possibilities. Schweiz Med Wochenschr 1970;100:301-303.
23. Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J R Statist Soc 1995;B57:289-300.
24. Ezekowitz JA, McAlister FA, Armstrong PW. Anemia is common in heart failure and is associated with poor outcomes: insights from a cohort of 12,065 patients with new-onset heart failure. Circulation 2003;107:223-225.
25. Opasich C, Cazzola M, Scelsi L, De Feo S, Bosimini E, Lagioia R, Febo O, Ferrari R, Fucili A, Moratti R, Tramarin R, Tavazzi L. Blunted erythropoietin production and defective iron supply for erythropoiesis as major causes of anaemia in patients with chronic heart failure. Eur Heart J 2005;26:2232-2237.
26. Nanas JN, Matsouka C, Karageorgopoulos D, Leonti A, Tsolakis E, Drakos SG, Tsagalou EP, Maroulidis GD, Alexopoulos GP, Kanakakis JE, Anastasiou-Nana MI. Etiology of anemia in patients with advanced heart failure. J Am Coll Cardiol 2006;48:2485-2489.
27. Grzeslo A, Jankowska EA, Witkowski T, Okonko DO, Majda J, Anker SD, Poole-Wilson PA, Banasiak W, Ponikowski P. Iron deficiency: a frequent and morbid condition in patients with chronic heart failure. Eur Heart J 2007;28 (Abstract Suppl):773.
28. Silverberg DS, Wexler D, Sheps D, Blum M, Keren G, Baruch R, Schwartz D, Yachnin T, Steinbruch S, Shapira I, Laniado S, Iaina A. The effect of correction of mild anemia in severe, resistant congestive heart failure using subcutaneous erythropoietin and intravenous iron: a randomized controlled study. J Am Coll Cardiol 2001;37:1775-1780.
29. Mancini DM, Katz SD, Lang CC, Lamanca J, Hudaihed A, Androne AS. Effect of erythropoietin on exercise capacity in patients with moderate to severe chronic heart failure. Circulation 2003;107:294-299.
30. Comin-Colet J, Ruiz S, Cladellas M, Rizzo M, Torres AG, Serrat R, Bruguera J. A pilot evaluation of the long-term effect of combined therapy with intravenous iron sucrose and erythropoietin in elderly patients with advanced chronic heart failure and cardio-renal anemia syndrome. J Cardiac Fail doi:10.1016/j.card-fail.2009.05.010. Published online ahead of print 29 June 2009.
31. Bolger AP, Bartlett FR, Penston HS, O'Leary J, Pollock N, Kaprielian R, Chapman CM. Intravenous iron alone for the treatment of anemia in patients with chronic heart failure. J Am Coll Cardiol 2006;48:1225-1227.
32. Toblli JE, Lombraña A, Duarte P, Di Gennaro F. Intravenous iron reduces NT-pro-brain natriuretic peptide in anemic patients with chronic heart failure and renal insufficiency. J Am Coll Cardiol 2007;50:1657-1665.
33. Okonko DO, Grzeslo A, Witkowski T, Mandal AK, Slater RM, Roughton M, Foldes G, Thum T, Majda J, Banasiak W, Missouris CG, Poole-Wilson PA, Anker SD, Ponikowski P. 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. J Am Coll Cardiol 2008;51:103-112.
34. Usmanov RI, Zueva EB, Silverberg DS, Shaked M. Intravenous iron without ery-thropoietin for the treatment of iron deficiency anemia in patients with moderate to severe congestive heart failure and chronic kidney insufficiency. J Nephrol 2008; 21:236-242.
35. Arutyunov GP, Bylova NA, Ivleva AY, Kobalava ZD. The safety of intravenous (i.v.) ferric carboxymaltose versus i.v. iron sucrose in patients with chronic heart failure (CHF) and chronic kidney disease (CKD) with iron deficiency (ID). Eur J Heart Fail 2009;8(Suppl. 2):ii71.