RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects With Symptomatic Left Ventricular Systolic Dysfunction and Anemia

The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Cardiovascular Disease; Anemia; Ventricular Dysfunction; Congestive Heart Failure
• Intervention / Treatment: Drug: Placebo; Drug: Darbepoetin alfa

Detailed Description

Several epidemiological studies have demonstrated an association between HF and anemia and correlation of increased risk for mortality and hospitalization with low hemoglobin in patients with HF. Earlier single-center interventional studies suggest that meaningful clinical benefits may be achieved by raising hemoglobin concentration in patients with symptomatic HF and anemia. Data from Amgen's completed phase 2 multi-center studies support this hypothesis and show that darbepoetin alfa is well tolerated in patients with symptomatic left ventricular systolic dysfunction and anemia and effectively raises hemoglobin. The pivotal phase 3 Study 20050222 RED-HF Trial is evaluating the effect of treatment with darbepoetin alfa on the composite risk of all-cause mortality or hospitalization for worsening HF in patients with symptomatic left ventricular systolic dysfunction and anemia. This study also evaluates the effect of darbepoetin alfa treatment on all-cause death, on cardiovascular death or hospitalization for worsening HF, and on patient-reported quality-of-life outcomes.

• Study Type: Interventional
• Enrollment (Actual): 2278
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1280AEB
    • Research Site
  • Buenos Aires, Argentina, 1155
    • Research Site
  • Buenos Aires, Argentina, B1708KCH
    • Research Site
  • Buenos Aires, Argentina, C1181ACH
    • Research Site
  • Buenos Aires, Argentina, C1405BCH
    • Research Site
  • Buenos Aires, Argentina, C1416DRJ
    • Research Site
  • Capital Federal, Argentina, C1221ADC
    • Research Site
  • Cordoba, Argentina, 5000
    • Research Site
  • Cordoba, Argentina, X5004CDT
    • Research Site
  • Corrientes, Argentina, W3400AMZ
    • Research Site
  • Mendoza, Argentina, 5500
    • Research Site
  • Salta, Argentina, A4406CLA
    • Research Site
  • Santa Fe, Argentina, 3000
    • Research Site
  • Buenos Aires
    • Adrogue, Buenos Aires, Argentina, 1836
      • Research Site
    • Bahia Blanca, Buenos Aires, Argentina, 8000
      • Research Site
    • Capital Federal, Buenos Aires, Argentina, C1426ANZ
      • Research Site
    • Capital Federal, Buenos Aires, Argentina, C1408INH
      • Research Site
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425
      • Research Site
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1118
      • Research Site
    • Coronel Suarez, Buenos Aires, Argentina, 7540
      • Research Site
    • La Plata, Buenos Aires, Argentina, 1900
      • Research Site
    • Mar del Plata, Buenos Aires, Argentina, B7600FZN
      • Research Site
    • Quilmes, Buenos Aires, Argentina, B1878GEG
      • Research Site
    • San Martin, Buenos Aires, Argentina, 1650
      • Research Site
  • Córdoba
    • Cordoba, Córdoba, Argentina, X5016KEH
      • Research Site
  • RÃ-o Negro
    • Cipolletti, RÃ-o Negro, Argentina, R8324EMD
      • Research Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000CVD
      • Research Site
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Research Site
    • Coffs Harbour, New South Wales, Australia, 2450
      • Research Site
    • Concord, New South Wales, Australia, 2139
      • Research Site
    • Gosford, New South Wales, Australia, 2250
      • Research Site
    • New Lambton Heights, New South Wales, Australia, 2305
      • Research Site
    • Randwick, New South Wales, Australia, 2031
      • Research Site
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • Research Site
    • Kippa Ring, Queensland, Australia, 4021
      • Research Site
    • Woolloongabba, Queensland, Australia, 4102
      • Research Site
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Research Site
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • Research Site
    • Heidelberg, Victoria, Australia, 3084
      • Research Site
    • Parkville, Victoria, Australia, 3052
      • Research Site
    • Prahran, Victoria, Australia, 3181
      • Research Site
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Research Site
• Austria
  • Innsbruck, Austria, 6020
    • Research Site
  • Linz, Austria, 4010
    • Research Site
  • Linz, Austria, 4021
    • Research Site
  • Salzburg, Austria, 5020
    • Research Site
  • Wels, Austria, 4600
    • Research Site
  • Wien, Austria, 1090
    • Research Site
  • Wien, Austria, 1150
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• Belgium
  • Aalst, Belgium, 9300
    • Research Site
  • Antwerpen, Belgium, 2060
    • Research Site
  • Antwerpen, Belgium, 2020
    • Research Site
  • Bonheiden, Belgium, 2820
    • Research Site
  • Brugge, Belgium, 8000
    • Research Site
  • Brussel, Belgium, 1090
    • Research Site
  • Bruxelles, Belgium, 1070
    • Research Site
  • Genk, Belgium, 3600
    • Research Site
  • Gent, Belgium, 9000
    • Research Site
  • Hasselt, Belgium, 3500
    • Research Site
  • Huy, Belgium, 4500
    • Research Site
  • Leuven, Belgium, 3000
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  • Roeselare, Belgium, 8800
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  • Turnhout, Belgium, 2300
    • Research Site
• Brazil
  • Rio De Janeiro, Brazil, 22271-100
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  • Rio de Janeiro, Brazil, 20551-030
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  • Rio de Janeiro, Brazil, 20020-020
    • Research Site
  • São Paulo, Brazil, 04025-002
    • Research Site
  • Bahia
    • Salvador, Bahia, Brazil, 40144-900
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  • Ceará
    • Fortaleza, Ceará, Brazil, 60864-194
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  • Goiás
    • Goiania, Goiás, Brazil, 74605-050
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  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30110-908
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  • Paraná
    • Curitiba, Paraná, Brazil, 80010-030
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  • Pernambuco
    • Recife, Pernambuco, Brazil, 50100-060
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  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
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    • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
      • Research Site
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90620-001
      • Research Site
  • São Paulo
    • Campinas, São Paulo, Brazil, 13059-740
      • Research Site
    • Riberão Preto, São Paulo, Brazil, 14048-900
      • Research Site
    • Sao Paulo, São Paulo, Brazil, 04012-909
      • Research Site
    • Sao Paulo, São Paulo, Brazil, 05403-900
      • Research Site
    • São José Do Rio Preto, São Paulo, Brazil, 15090-000
      • Research Site
• Bulgaria
  • Dimitrovgrad, Bulgaria, 6400
    • Research Site
  • Haskovo, Bulgaria, 6300
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  • Pleven, Bulgaria, 5800
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  • Plovdiv, Bulgaria, 4003
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  • Plovdiv, Bulgaria, 4000
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  • Plovdiv, Bulgaria, 4002
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  • Rouse, Bulgaria, 7002
    • Research Site
  • Sofia, Bulgaria, 1431
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  • Sofia, Bulgaria, 1202
    • Research Site
  • Sofia, Bulgaria, 1527
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  • Sofia, Bulgaria, 1233
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  • Sofia, Bulgaria, 1309
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  • Sofia, Bulgaria, 1606
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  • Varna, Bulgaria, 9010
    • Research Site
  • Veliko Tarnovo, Bulgaria, 5000
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• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2E 7C5
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    • Edmonton, Alberta, Canada, T6G 2B7
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    • Edmonton, Alberta, Canada, T6K 4C1
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  • British Columbia
    • Campbell River, British Columbia, Canada, V9W 5Y4
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    • Surrey, British Columbia, Canada, V3V 1Z2
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  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
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    • Winnipeg, Manitoba, Canada, R3T 2E8
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  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
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  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
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  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
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    • Cambridge, Ontario, Canada, N1R 7R1
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    • Hamilton, Ontario, Canada, L8L 2X2
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    • Kingston, Ontario, Canada, K7L 1C2
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    • London, Ontario, Canada, N6A 5A5
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    • Mississauga, Ontario, Canada, L5B 4A2
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    • North York, Ontario, Canada, M2K 2W2
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    • Ottawa, Ontario, Canada, K1Y 4W7
      • Research Site
    • Scarborough, Ontario, Canada, M1E 5E9
      • Research Site
    • Scarborough, Ontario, Canada, M1P 2V5
      • Research Site
    • Toronto, Ontario, Canada, M5G 1X5
      • Research Site
    • Toronto, Ontario, Canada, M5G 2C4
      • Research Site
    • Toronto, Ontario, Canada, M5B 1W8
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Research Site
    • Montreal, Quebec, Canada, H3A 1A1
      • Research Site
    • Montreal, Quebec, Canada, H3G 1A4
      • Research Site
    • Montreal, Quebec, Canada, H2W 1T8
      • Research Site
    • Montreal, Quebec, Canada, H2W 1T7
      • Research Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Research Site
    • St-Jérôme, Quebec, Canada, J7Z 5T3
      • Research Site
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P 3X3
      • Research Site
    • Saskatoon, Saskatchewan, Canada, S7H 5H9
      • Research Site
• Chile
  • Osorno, Chile
    • Research Site
  • Santiago, Chile
    • Research Site
  • Santiago, Chile, 8320000
    • Research Site
  • Santiago, Chile, 8330032
    • Research Site
  • Santiago, Chile, 7500922
    • Research Site
  • Temuco, Chile, 4781151
    • Research Site
  • Vina del Mar, Chile
    • Research Site
  • Cachapoal
    • Rancagua, Cachapoal, Chile, 2841959
      • Research Site
  • Elqui
    • La Serena, Elqui, Chile, 1731295
      • Research Site
  • Santiago
    • San Miguel, Santiago, Chile, 8900085
      • Research Site
• Czechia
  • Benesov, Czechia, 256 01
    • Research Site
  • Brno, Czechia, 656 91
    • Research Site
  • Ceske Budejovice, Czechia, 370 87
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  • Jihlava, Czechia, 586 01
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  • Karlovy Vary, Czechia, 360 01
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  • Pardubice, Czechia, 530 02
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  • Praha 1, Czechia, 110 00
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  • Praha 10, Czechia, 100 34
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  • Praha 10, Czechia, 108 00
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  • Praha 2, Czechia, 128 08
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  • Praha 2, Czechia, 120 00
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  • Pribram 8, Czechia, 261 01
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  • Tabor, Czechia, 390 03
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  • Usti nad Labem, Czechia, 401 13
    • Research Site
• Denmark
  • Fredericia, Denmark, 7000
    • Research Site
  • Frederiksberg, Denmark, 2000
    • Research Site
  • Frederikshavn, Denmark, 9900
    • Research Site
  • Glostrup, Denmark, 2600
    • Research Site
  • Hellerup, Denmark, 2900
    • Research Site
  • Herlev, Denmark, 2730
    • Research Site
  • Horsens, Denmark, 8700
    • Research Site
  • Hvidovre, Denmark, 2650
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  • København S, Denmark, 2300
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  • København Ø, Denmark, 2011
    • Research Site
  • Køge, Denmark, 4600
    • Research Site
  • Odense, Denmark, 5000
    • Research Site
  • Roskilde, Denmark, 4000
    • Research Site
  • Svendborg, Denmark, 5700
    • Research Site
• Estonia
  • Pärnu, Estonia, 80010
    • Research Site
  • Tallinn, Estonia, 10617
    • Research Site
  • Tallinn, Estonia, 13419
    • Research Site
  • Tallinn, Estonia, 10138
    • Research Site
• Finland
  • Espoo, Finland, 00029
    • Research Site
  • Helsinki, Finland, 00260
    • Research Site
  • Lahti, Finland, 15110
    • Research Site
  • Seinajoki, Finland, 60100
    • Research Site
• France
  • Bron, France, 69500
    • Research Site
  • Caen Cedex 14, France, 14033
    • Research Site
  • Cholet Cedex, France, 49325
    • Research Site
  • Créteil Cedex, France, 94010
    • Research Site
  • Douai Cedex, France, 59507
    • Research Site
  • Grenoble Cedex 9, France, 38043
    • Research Site
  • Lille Cedex, France, 59037
    • Research Site
  • Montfermeil, France, 93370
    • Research Site
  • Montpellier cedex 05, France, 34295
    • Research Site
  • Nice Cedex 01, France, 06002
    • Research Site
  • Paris, France, 75010
    • Research Site
  • Paris Cedex 13, France, 75651
    • Research Site
  • Pessac Cedex, France, 33604
    • Research Site
  • Poitiers, France, 86000
    • Research Site
  • Pontoise Cedex, France, 95301
    • Research Site
  • Rouen Cedex, France, 76031
    • Research Site
  • Saint Herblain, France, 44800
    • Research Site
  • Strasbourg, France, 67091
    • Research Site
  • Toulouse Cedex 09, France, 31403
    • Research Site
  • Vandoeuvre-les-Nancy, France, 54511
    • Research Site
• Germany
  • Bad Tölz, Germany, 83646
    • Research Site
  • Berlin, Germany, 10787
    • Research Site
  • Berlin, Germany, 12200
    • Research Site
  • Berlin, Germany, 13353
    • Research Site
  • Bochum, Germany, 44789
    • Research Site
  • Bremen, Germany, 28277
    • Research Site
  • Frankfurt, Germany, 60594
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  • Georgsmarienhütte, Germany, 49124
    • Research Site
  • Göttingen, Germany, 37075
    • Research Site
  • Hamburg, Germany, 20246
    • Research Site
  • Hamburg, Germany, 20148
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  • Hannover, Germany, 30625
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  • Heidelberg, Germany, 69120
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  • Heidelberg, Germany, 69115
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  • Homburg, Germany, 66421
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  • Ingelheim, Germany, 55218
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  • Köln, Germany, 50924
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  • Lahr, Germany, 77933
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  • Leipzig, Germany, 04289
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  • Mainz, Germany, 55131
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  • Marburg, Germany, 35037
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  • Nürnberg, Germany, 90402
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  • Schwedt, Germany, 16303
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  • Stuttgart, Germany, 70376
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  • Witten, Germany, 58455
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• Hong Kong
  • Hong Kong, Hong Kong
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  • New Territories, Hong Kong, 00000
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• Hungary
  • Bekescsaba, Hungary, 5600
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  • Budapest, Hungary, 1115
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  • Budapest, Hungary, 1135
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  • Budapest, Hungary, 1096
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  • Budapest, Hungary, 1106
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  • Budapest, Hungary, 1027
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  • Budapest, Hungary, 1075
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  • Debrecen, Hungary, 4032
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  • Gyor, Hungary, 9023
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  • Kalocsa, Hungary, 6300
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  • Kecskemet, Hungary, 6000
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  • Sopron, Hungary, 9400
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  • Szeged, Hungary, 6720
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  • Szekesfehervar, Hungary, 8000
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  • Szekszard, Hungary, 7100
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  • Szolnok, Hungary, 5000
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  • Veszprem, Hungary, 8200
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  • Zalaegerszeg, Hungary, 8900
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• India
  • Mumbai, India, 400 020
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  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500 001
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    • Hyderabad, Andhra Pradesh, India, 500 033
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    • Hyderabad, Andhra Pradesh, India, 500 063
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  • Delhi
    • New Delhi, Delhi, India, 110 025
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    • New Delhi, Delhi, India, 110 029
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  • Gujarat
    • Ahmedabad, Gujarat, India, 380 006
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    • Ahmedabad, Gujarat, India, 380 060
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    • Ahmedabad, Gujarat, India, 382 428
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  • Haryana
    • Gurgaon, Haryana, India, 122 001
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  • Karnataka
    • Bangalore, Karnataka, India, 560 054
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    • Bangalore, Karnataka, India, 560 034
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  • Maharashtra
    • Mumbai, Maharashtra, India, 400 022
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    • Nagpur, Maharashtra, India, 400 012
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    • Nashik, Maharashtra, India, 422 005
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    • Pune, Maharashtra, India, 411 004
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    • Pune, Maharashtra, India, 411 001
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    • Pune, Maharashtra, India, 411 006
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    • Pune, Maharashtra, India, 411 011
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    • Pune, Maharashtra, India, 411 016
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    • Pune, Maharashtra, India, 411 033
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  • Punjab
    • Ludhiana, Punjab, India, 141 001
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  • Rajasthan
    • Bikaner, Rajasthan, India, 334 003
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  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 006
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    • Chennai, Tamil Nadu, India, 600 037
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    • Chennai, Tamil Nadu, India, 600 081
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    • Coimbatore, Tamil Nadu, India, 641 004
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    • Coimbatore, Tamil Nadu, India, 641 014
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    • Madurai, Tamil Nadu, India, 625 020
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  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226 014
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• Israel
  • Askelon, Israel, 78278
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  • Beer Sheva, Israel, 84101
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  • Beer Yaakov, Israel, 70300
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  • Givatayim, Israel, 53583
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  • Hadera, Israel, 38100
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  • Haifa, Israel, 34362
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  • Holon, Israel, 58100
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  • Jerusalem, Israel, 91031
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  • Jerusalem, Israel, 91200
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  • Kfar Saba, Israel, 44281
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  • Safed, Israel, 13100
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  • Tel-Aviv, Israel, 64239
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• Italy
  • Arezzo, Italy, 52100
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  • Bergamo, Italy, 24128
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  • Cesenatico (FC), Italy, 47042
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  • Cetraro CS, Italy, 87022
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  • Cortona AR, Italy, 52044
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  • Eboli, Italy, 84025
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  • Ferrara, Italy, 44100
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  • Forlì, Italy, 47100
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  • Milano, Italy, 20138
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  • Napoli, Italy, 80131
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  • Oliveto Citra SA, Italy, 84020
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  • Palermo, Italy, 90126
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  • Palmanova UD, Italy, 33057
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  • Pavia, Italy, 27100
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  • Roma, Italy, 00152
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  • Roma, Italy, 00184
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  • Rozzano MI, Italy, 20089
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  • San Bonifacio VR, Italy, 37047
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  • Torino, Italy, 10126
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  • Trento, Italy, 38100
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  • Udine, Italy, 33100
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• Latvia
  • Daugavpils, Latvia, 5417
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  • Ogre, Latvia, 5001
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• Lithuania
  • Alytus, Lithuania, 62114
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  • Kaunas, Lithuania, 50009
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  • Kaunas, Lithuania, 44320
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  • Vilnius, Lithuania, 10309
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• Mexico
  • Baja California, Mexico, 21397
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  • Distrito Federal, Mexico, 06760
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  • Distrito Federal
    • Mexico City, Distrito Federal, Mexico, 14080
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  • Jalisco
    • Guadajalara, Jalisco, Mexico, 44100
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    • Monterrey, Nuevo León, Mexico, 64000
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  • San Luis PotosÃ-
    • San Luis Potosi, San Luis PotosÃ-, Mexico, 78240
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    • Xalapa, Veracruz, Mexico, 91140
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    • Merida, Yucatán, Mexico, 97000
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• Netherlands
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• Norway
  • Arendal, Norway, 4809
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  • Stavanger, Norway, 4095
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  • Ã…lesund, Norway, 6026
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• Poland
  • Bialystok, Poland, 15-276
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  • Gdansk, Poland, 80-952
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  • Gdynia, Poland, 81-519
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  • Gdynia, Poland, 81-423
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  • Katowice, Poland, 40-635
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  • Krakow, Poland, 31-202
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  • Krakow, Poland, 30-092
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  • Lublin, Poland, 20-954
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  • Stalowa Wola, Poland, 37-450
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  • Tarnow, Poland, 33-100
    • Research Site
  • Walbrzych, Poland, 58-309
    • Research Site
  • Warszawa, Poland, 01-211
    • Research Site
  • Warszawa, Poland, 04-628
    • Research Site
  • Warszawa, Poland, 01-809
    • Research Site
  • Warszawa, Poland, 03-242
    • Research Site
  • Warszawa, Poland, 04-238
    • Research Site
  • Wroclaw, Poland, 50-981
    • Research Site
  • Zabrze, Poland, 41-800
    • Research Site
  • Zielona Gora, Poland, 65-046
    • Research Site
• Portugal
  • Coimbra, Portugal, 3000-075
    • Research Site
  • Faro, Portugal, 8000-386
    • Research Site
  • Lisboa, Portugal, 1449-005
    • Research Site
  • Lisbon, Portugal, 1169-024
    • Research Site
• Puerto Rico
  • San Juan, Puerto Rico, 00935
    • Research Site
• Romania
  • Arad, Romania, 310031
    • Research Site
  • Bacau, Romania, 600114
    • Research Site
  • Brasov, Romania, 500157
    • Research Site
  • Bucuresti, Romania, 030171
    • Research Site
  • Bucuresti, Romania, 021659
    • Research Site
  • Bucuresti, Romania, 022328
    • Research Site
  • Bucuresti, Romania, 011461
    • Research Site
  • Iasi, Romania, 700111
    • Research Site
  • Oradea, Romania, 410169
    • Research Site
  • Sibiu, Romania, 550245
    • Research Site
  • Targu Mures, Romania, 540136
    • Research Site
  • Targu Mures, Romania, 540103
    • Research Site
  • Timisoara, Romania, 300041
    • Research Site
  • Timisoara, Romania, 300310
    • Research Site
• Russian Federation
  • Moscow, Russian Federation, 115093
    • Research Site
  • Moscow, Russian Federation, 125315
    • Research Site
  • Moscow, Russian Federation, 129090
    • Research Site
  • Moscow, Russian Federation, 119992
    • Research Site
  • Moscow, Russian Federation, 121552
    • Research Site
  • Moscow, Russian Federation, 109263
    • Research Site
  • Moscow, Russian Federation, 107014
    • Research Site
  • Moscow, Russian Federation, 127473
    • Research Site
  • Moscow, Russian Federation, 115516
    • Research Site
  • Moscow, Russian Federation, 127018
    • Research Site
  • Moscow, Russian Federation, 117292
    • Research Site
  • Moscow, Russian Federation, 119620
    • Research Site
  • Moscow, Russian Federation, 117513
    • Research Site
  • Moscow, Russian Federation, 119435
    • Research Site
  • Moscow, Russian Federation, 121359
    • Research Site
  • Moscow, Russian Federation, 125206
    • Research Site
  • Moscow, Russian Federation, 127644
    • Research Site
  • Saint Petersburg, Russian Federation, 192242
    • Research Site
  • Saint Petersburg, Russian Federation, 197022
    • Research Site
  • Sankt-Petersburg, Russian Federation, 194156
    • Research Site
  • St Petersburg, Russian Federation, 198205
    • Research Site
  • St. Petersburg, Russian Federation, 199106
    • Research Site
  • St. Petersburg, Russian Federation, 194017
    • Research Site
  • Volgograd, Russian Federation, 400008
    • Research Site
• Slovakia
  • Bardejov, Slovakia, 085 01
    • Research Site
  • Bratislava, Slovakia, 811 00
    • Research Site
  • Kosice, Slovakia, 040 22
    • Research Site
  • Levice, Slovakia, 934 48
    • Research Site
  • Lucenec, Slovakia, 984 01
    • Research Site
  • Nitra, Slovakia, 949 01
    • Research Site
  • Nitra, Slovakia, 950 01
    • Research Site
  • Presov, Slovakia, 080 01
    • Research Site
  • Zilina, Slovakia, 012 07
    • Research Site
• South Africa
  • Cape Town, South Africa, 7530
    • Research Site
  • Cape Town, South Africa, 7405
    • Research Site
  • Gauteng
    • Boksburg, Gauteng, South Africa, 1459
      • Research Site
    • Johannesburg, Gauteng, South Africa, 2193
      • Research Site
    • Johannesburg, Gauteng, South Africa, 2157
      • Research Site
    • Pretoria, Gauteng, South Africa, 0002
      • Research Site
    • Soweto, Gauteng, South Africa, 2013
      • Research Site
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4001
      • Research Site
    • Durban, KwaZulu-Natal, South Africa, 4052
      • Research Site
    • Durban, KwaZulu-Natal, South Africa, 4068
      • Research Site
  • Western Cape
    • Parow, Western Cape, South Africa, 7505
      • Research Site
    • Somerset West, Western Cape, South Africa, 7130
      • Research Site
    • Worcester, Western Cape, South Africa, 6850
      • Research Site
• Spain
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • AndalucÃ-a
    • Córdoba, AndalucÃ-a, Spain, 14004
      • Research Site
    • Granada, AndalucÃ-a, Spain, 18014
      • Research Site
    • Málaga, AndalucÃ-a, Spain, 29010
      • Research Site
  • Asturias
    • Oviedo, Asturias, Spain, 33006
      • Research Site
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Research Site
  • Cataluña
    • Badalona, Cataluña, Spain, 08916
      • Research Site
    • Barcelona, Cataluña, Spain, 08003
      • Research Site
    • Barcelona, Cataluña, Spain, 08035
      • Research Site
    • Barcelona, Cataluña, Spain, 08036
      • Research Site
    • Barcelona, Cataluña, Spain, 08041
      • Research Site
    • Sabadell, Cataluña, Spain, 08208
      • Research Site
    • Tarragona, Cataluña, Spain, 43007
      • Research Site
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46014
      • Research Site
  • Galicia
    • Santiago de Compostela, Galicia, Spain, 15706
      • Research Site
  • Madrid
    • Majadhonda, Madrid, Spain, 28222
      • Research Site
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Research Site
  • PaÃ-s Vasco
    • Galdakao, PaÃ-s Vasco, Spain, 48960
      • Research Site
• Sweden
  • Danderyd, Sweden, 182 88
    • Research Site
  • Göteborg, Sweden, 413 45
    • Research Site
  • Göteborg, Sweden, 416 85
    • Research Site
  • Linköping, Sweden, 581 85
    • Research Site
  • Malmö, Sweden, 205 02
    • Research Site
  • Mölndal, Sweden, 431 80
    • Research Site
  • Stockholm, Sweden, 112 81
    • Research Site
  • Sundsvall, Sweden, 851 56
    • Research Site
  • UmeÃ¥, Sweden, 901 85
    • Research Site
  • Uppsala, Sweden, 751 85
    • Research Site
  • Ã-rebro, Sweden, 701 85
    • Research Site
• Switzerland
  • Lugano, Switzerland, 6900
    • Research Site
  • St. Gallen, Switzerland, 9007
    • Research Site
• United Kingdom
  • Barnet, United Kingdom, EN5 3DJ
    • Research Site
  • Belfast, United Kingdom, BT12 6BA
    • Research Site
  • Birmingham, United Kingdom, B757RR
    • Research Site
  • Bradford, United Kingdom, BD9 6RJ
    • Research Site
  • Bridlington, United Kingdom, YO164QP
    • Research Site
  • Cottingham, United Kingdom, HU16 5JQ
    • Research Site
  • Coventry, United Kingdom, CV2 2DX
    • Research Site
  • Glasgow, United Kingdom, G51 4TF
    • Research Site
  • Glasgow, United Kingdom, G12 8TA
    • Research Site
  • Harrow, United Kingdom, HA1 3UJ
    • Research Site
  • Kirkcaldy, United Kingdom, KY2 5AH
    • Research Site
  • Leeds, United Kingdom, LS9 7TF
    • Research Site
  • Leeds, United Kingdom, LS1 3EX
    • Research Site
  • Leicester, United Kingdom, LE3 9QP
    • Research Site
  • Livingston, United Kingdom, EH54 6PP
    • Research Site
  • London, United Kingdom, SE1 7EH
    • Research Site
  • Manchester, United Kingdom, M8 5RB
    • Research Site
  • Romford, United Kingdom, RM7 0AG
    • Research Site
  • Stockport, United Kingdom, SK2 7JE
    • Research Site
  • Worcester, United Kingdom, WR5 1DD
    • Research Site
  • Worthing, United Kingdom, BN11 2DH
    • Research Site
  • York, United Kingdom, YO31 8HE
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Research Site
    • Birmingham, Alabama, United States, 35211
      • Research Site
    • Huntsville, Alabama, United States, 35801
      • Research Site
    • Mobile, Alabama, United States, 36608
      • Research Site
  • Arizona
    • Gilbert, Arizona, United States, 85296
      • Research Site
    • Mesa, Arizona, United States, 85206
      • Research Site
    • Scottsdale, Arizona, United States, 85251
      • Research Site
    • Tucson, Arizona, United States, 85723
      • Research Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Research Site
    • Little Rock, Arkansas, United States, 72204
      • Research Site
  • California
    • Anaheim, California, United States, 92801
      • Research Site
    • Buena Park, California, United States, 90621
      • Research Site
    • Corona, California, United States, 92879
      • Research Site
    • Culver City, California, United States, 90232
      • Research Site
    • Downey, California, United States, 90241
      • Research Site
    • La Jolla, California, United States, 92037
      • Research Site
    • Lancaster, California, United States, 93534
      • Research Site
    • Larkspur, California, United States, 94939
      • Research Site
    • Loma Linda, California, United States, 92354
      • Research Site
    • Long Beach, California, United States, 90822
      • Research Site
    • Los Angeles, California, United States, 90017
      • Research Site
    • Los Angeles, California, United States, 90048
      • Research Site
    • Los Angeles, California, United States, 90073
      • Research Site
    • Los Angeles, California, United States, 90024
      • Research Site
    • Los Angeles, California, United States, 90033-1026
      • Research Site
    • Modesto, California, United States, 95355
      • Research Site
    • Oakland, California, United States, 94609
      • Research Site
    • Pasadena, California, United States, 91105
      • Research Site
    • Redondo Beach, California, United States, 90277
      • Research Site
    • Sacramento, California, United States, 95825
      • Research Site
    • Sacramento, California, United States, 95819
      • Research Site
    • San Diego, California, United States, 92120
      • Research Site
    • San Francisco, California, United States, 94115
      • Research Site
    • San Francisco, California, United States, 94118
      • Research Site
    • Santa Monica, California, United States, 90404
      • Research Site
    • Santa Rosa, California, United States, 95405
      • Research Site
    • Sylmar, California, United States, 91342
      • Research Site
    • Walnut Creek, California, United States, 94598
      • Research Site
    • Westlake Village, California, United States, 91361
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Research Site
    • Colorado Springs, Colorado, United States, 80907
      • Research Site
    • Denver, Colorado, United States, 80218
      • Research Site
    • Littleton, Colorado, United States, 80120
      • Research Site
    • Loveland, Colorado, United States, 80538
      • Research Site
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Research Site
    • Fairfield, Connecticut, United States, 06430
      • Research Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Research Site
    • Washington, District of Columbia, United States, 20422
      • Research Site
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Research Site
    • Jacksonville, Florida, United States, 32207
      • Research Site
    • Jacksonville, Florida, United States, 32258
      • Research Site
    • Jacksonville Beach, Florida, United States, 32250
      • Research Site
    • Jupiter, Florida, United States, 33458
      • Research Site
    • Melbourne, Florida, United States, 32901
      • Research Site
    • Miami, Florida, United States, 33133
      • Research Site
    • Miami Beach, Florida, United States, 33140
      • Research Site
    • Orlando, Florida, United States, 32803
      • Research Site
    • Port Charlotte, Florida, United States, 33952
      • Research Site
    • Safety Harbor, Florida, United States, 34695
      • Research Site
    • Saint Petersburg, Florida, United States, 33705
      • Research Site
    • Saint Petersburg, Florida, United States, 33701
      • Research Site
    • Sarasota, Florida, United States, 34239
      • Research Site
    • Tamarac, Florida, United States, 33321
      • Research Site
    • Tampa, Florida, United States, 33609
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Research Site
    • Atlanta, Georgia, United States, 30308
      • Research Site
    • Augusta, Georgia, United States, 30901
      • Research Site
    • Covington, Georgia, United States, 30014
      • Research Site
    • Rome, Georgia, United States, 30165
      • Research Site
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Research Site
    • Elk Grove Village, Illinois, United States, 60007
      • Research Site
    • Evanston, Illinois, United States, 60202
      • Research Site
    • Hinsdale, Illinois, United States, 60521
      • Research Site
    • Maywood, Illinois, United States, 60153
      • Research Site
    • Melrose Park, Illinois, United States, 60160
      • Research Site
    • Oak Lawn, Illinois, United States, 60453
      • Research Site
    • Oakbrook Terrace, Illinois, United States, 60181
      • Research Site
    • Peoria, Illinois, United States, 61606
      • Research Site
    • Rockford, Illinois, United States, 61107
      • Research Site
    • Springfield, Illinois, United States, 62701
      • Research Site
    • Springfield, Illinois, United States, 62702
      • Research Site
  • Indiana
    • Anderson, Indiana, United States, 46011
      • Research Site
    • Fort Wayne, Indiana, United States, 46805
      • Research Site
    • Indianapolis, Indiana, United States, 46260
      • Research Site
    • Indianapolis, Indiana, United States, 46202
      • Research Site
    • Indianapolis, Indiana, United States, 46250
      • Research Site
    • Jeffersonville, Indiana, United States, 47130
      • Research Site
    • Valparaiso, Indiana, United States, 46383
      • Research Site
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Research Site
    • Iowa City, Iowa, United States, 52242
      • Research Site
    • Iowa City, Iowa, United States, 52245
      • Research Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Research Site
    • Olathe, Kansas, United States, 66061
      • Research Site
    • Wichita, Kansas, United States, 67214
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Research Site
    • Louisville, Kentucky, United States, 40207
      • Research Site
    • Madisonville, Kentucky, United States, 42431
      • Research Site
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Research Site
    • Covington, Louisiana, United States, 70433
      • Research Site
    • Lake Charles, Louisiana, United States, 70601
      • Research Site
    • Marrero, Louisiana, United States, 70072
      • Research Site
    • Slidell, Louisiana, United States, 70458
      • Research Site
  • Maine
    • South Portland, Maine, United States, 04106
      • Research Site
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Research Site
    • Baltimore, Maryland, United States, 21287
      • Research Site
    • Salisbury, Maryland, United States, 21804
      • Research Site
  • Massachusetts
    • Ayer, Massachusetts, United States, 01432
      • Research Site
    • Boston, Massachusetts, United States, 02115
      • Research Site
    • Boston, Massachusetts, United States, 02118
      • Research Site
    • Haverhill, Massachusetts, United States, 01830
      • Research Site
    • Natick, Massachusetts, United States, 01760
      • Research Site
    • North Dartmouth, Massachusetts, United States, 02747
      • Research Site
    • West Roxbury, Massachusetts, United States, 02132
      • Research Site
    • Whitman, Massachusetts, United States, 02382
      • Research Site
    • Worcester, Massachusetts, United States, 01655
      • Research Site
    • Worcester, Massachusetts, United States, 01604
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Research Site
    • Detroit, Michigan, United States, 48201
      • Research Site
    • Grand Rapids, Michigan, United States, 49503
      • Research Site
    • Lansing, Michigan, United States, 48910
      • Research Site
    • Muskegon, Michigan, United States, 49444
      • Research Site
    • Petoskey, Michigan, United States, 49770
      • Research Site
    • Saginaw, Michigan, United States, 48601
      • Research Site
    • Southfield, Michigan, United States, 48075
      • Research Site
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Research Site
    • Minneapolis, Minnesota, United States, 55455
      • Research Site
    • Minneapolis, Minnesota, United States, 55417
      • Research Site
    • Minneapolis, Minnesota, United States, 55304
      • Research Site
    • Saint Louis Park, Minnesota, United States, 55426
      • Research Site
    • Saint Paul, Minnesota, United States, 55102
      • Research Site
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Research Site
    • Kansas City, Missouri, United States, 64111
      • Research Site
    • Kansas City, Missouri, United States, 64108
      • Research Site
    • Saint Louis, Missouri, United States, 63110
      • Research Site
    • Saint Louis, Missouri, United States, 63104
      • Research Site
    • Saint Louis, Missouri, United States, 63122
      • Research Site
  • Montana
    • Kalispell, Montana, United States, 59901
      • Research Site
    • Missoula, Montana, United States, 59802
      • Research Site
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Research Site
    • Lincoln, Nebraska, United States, 68506
      • Research Site
    • Lincoln, Nebraska, United States, 68526
      • Research Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Research Site
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Research Site
    • Morristown, New Jersey, United States, 07962
      • Research Site
    • Newark, New Jersey, United States, 07103
      • Research Site
    • Newark, New Jersey, United States, 07112
      • Research Site
    • Summit, New Jersey, United States, 07902
      • Research Site
    • Westwood, New Jersey, United States, 07675
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Research Site
  • New York
    • Bronx, New York, United States, 10467
      • Research Site
    • Bronx, New York, United States, 10461
      • Research Site
    • Buffalo, New York, United States, 14221
      • Research Site
    • Cortlandt Manor, New York, United States, 10567
      • Research Site
    • Flushing, New York, United States, 11355
      • Research Site
    • Garden City, New York, United States, 11530
      • Research Site
    • Johnson City, New York, United States, 13790
      • Research Site
    • Kingston, New York, United States, 12401
      • Research Site
    • New York, New York, United States, 10016
      • Research Site
    • New York, New York, United States, 10021
      • Research Site
    • New York, New York, United States, 10032
      • Research Site
    • New York, New York, United States, 10029
      • Research Site
    • New York, New York, United States, 10019
      • Research Site
    • New York, New York, United States, 10001
      • Research Site
    • Rochester, New York, United States, 14618
      • Research Site
    • Staten Island, New York, United States, 10305
      • Research Site
    • Syracuse, New York, United States, 13210
      • Research Site
    • Troy, New York, United States, 12180
      • Research Site
    • West Islip, New York, United States, 11795
      • Research Site
    • Williamsville, New York, United States, 14221
      • Research Site
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Research Site
    • Burlington, North Carolina, United States, 27215
      • Research Site
    • Chapel Hill, North Carolina, United States, 27599
      • Research Site
    • Charlotte, North Carolina, United States, 28204
      • Research Site
    • Durham, North Carolina, United States, 27705
      • Research Site
    • Gastonia, North Carolina, United States, 28054
      • Research Site
    • Greensboro, North Carolina, United States, 27403
      • Research Site
    • New Bern, North Carolina, United States, 28562
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site
    • Winston-Salem, North Carolina, United States, 27157
      • Research Site
  • Ohio
    • Akron, Ohio, United States, 44307
      • Research Site
    • Canton, Ohio, United States, 44710
      • Research Site
    • Cincinnati, Ohio, United States, 45267
      • Research Site
    • Cleveland, Ohio, United States, 44195
      • Research Site
    • Cleveland, Ohio, United States, 44109
      • Research Site
    • Cleveland, Ohio, United States, 44106
      • Research Site
    • Dayton, Ohio, United States, 45414
      • Research Site
    • Garfield Heights, Ohio, United States, 44125
      • Research Site
    • Mayfield Heights, Ohio, United States, 44124
      • Research Site
    • Sandusky, Ohio, United States, 44870
      • Research Site
    • Toledo, Ohio, United States, 43606
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Research Site
    • Oklahoma City, Oklahoma, United States, 73104
      • Research Site
    • Oklahoma City, Oklahoma, United States, 73120
      • Research Site
    • Oklahoma City, Oklahoma, United States, 73109
      • Research Site
    • Tulsa, Oklahoma, United States, 74104
      • Research Site
  • Oregon
    • Bend, Oregon, United States, 97701
      • Research Site
    • Hillsboro, Oregon, United States, 97123
      • Research Site
    • Portland, Oregon, United States, 97213
      • Research Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18106
      • Research Site
    • Hershey, Pennsylvania, United States, 17033
      • Research Site
    • Lancaster, Pennsylvania, United States, 17603
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19107
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19104
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19140
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19102
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19141
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15212
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15224
      • Research Site
    • Sayre, Pennsylvania, United States, 18840
      • Research Site
    • Wyomissing, Pennsylvania, United States, 19610
      • Research Site
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • Research Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Research Site
    • Charleston, South Carolina, United States, 29401
      • Research Site
    • Charleston, South Carolina, United States, 29403
      • Research Site
    • Columbia, South Carolina, United States, 29204
      • Research Site
    • Orangeburg, South Carolina, United States, 29115
      • Research Site
    • Spartanburg, South Carolina, United States, 29303
      • Research Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Research Site
    • Germantown, Tennessee, United States, 38138
      • Research Site
    • Jackson, Tennessee, United States, 38305
      • Research Site
    • Memphis, Tennessee, United States, 38120
      • Research Site
    • Memphis, Tennessee, United States, 38104
      • Research Site
    • Nashville, Tennessee, United States, 37203
      • Research Site
    • Nashville, Tennessee, United States, 37232-8802
      • Research Site
    • Tullahoma, Tennessee, United States, 37388
      • Research Site
  • Texas
    • Beaumont, Texas, United States, 77702
      • Research Site
    • Dallas, Texas, United States, 75390
      • Research Site
    • Dallas, Texas, United States, 75231
      • Research Site
    • Dallas, Texas, United States, 75230
      • Research Site
    • Dallas, Texas, United States, 75216
      • Research Site
    • Dallas, Texas, United States, 75226
      • Research Site
    • Galveston, Texas, United States, 77555
      • Research Site
    • Houston, Texas, United States, 77030
      • Research Site
    • Houston, Texas, United States, 77074
      • Research Site
    • Houston, Texas, United States, 77004
      • Research Site
    • Lubbock, Texas, United States, 79410
      • Research Site
    • Odessa, Texas, United States, 79763
      • Research Site
    • San Antonio, Texas, United States, 78217
      • Research Site
    • Tyler, Texas, United States, 75708
      • Research Site
  • Utah
    • Salt Lake City, Utah, United States, 84148
      • Research Site
  • Virginia
    • Annandale, Virginia, United States, 22003
      • Research Site
    • Midlothian, Virginia, United States, 23114
      • Research Site
    • Richmond, Virginia, United States, 23249
      • Research Site
    • Roanoke, Virginia, United States, 24014
      • Research Site
  • Washington
    • Bellingham, Washington, United States, 98225
      • Research Site
    • Kirkland, Washington, United States, 98034
      • Research Site
    • Seattle, Washington, United States, 98195
      • Research Site
    • Tacoma, Washington, United States, 98405
      • Research Site
  • Wisconsin
    • Beloit, Wisconsin, United States, 53511
      • Research Site
    • Madison, Wisconsin, United States, 53792
      • Research Site
    • Madison, Wisconsin, United States, 53707
      • Research Site
    • Milwaukee, Wisconsin, United States, 53215
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Heart failure of at least 3 months duration and of New York Heart Association (NYHA) class II, III, or IV
• hemoglobin between 9.0 g/dL and 12.0 g/dL
• left ventricular ejection fraction equal to or less than 40%

Exclusion Criteria:

• Transferrin saturation (Tsat) < 15%
• Blood pressure > 160/100 mm Hg
• Heart failure primarily due to valvular heart disease or clinically significant valvular heart disease that might lead to surgical correction within 12 months of randomization
• Recipient of a major organ transplant or receiving renal replacement therapy
• Serum creatinine > 3.0 mg/dL (> 265 µmol/L)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Darbepoetin alfa; Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.	Drug: Darbepoetin alfa; Administered by subcutaneous injection; Other Names: Aranesp®
Placebo Comparator: Placebo; Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.	Drug: Placebo; Placebo subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to All Cause Death or First Hospitalization for Worsening Heart Failure	Time to death from any cause or first hospital admission for worsening heart failure (adjudicated by the Clinical Endpoint Committee), whichever occurred first, estimated by Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.	From randomization to the end of study; maximum time on study was 73 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Death From Any Cause	Time from randomization to death due to any cause, estimated by the Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.	From randomization to the end of study; maximum time on study was 73 months
Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure	Time to cardiovascular death or first hospital admission for worsening heart failure, whichever occured first, estimated using the Kaplan Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.	From randomization to the end of study; maximum time on study was 73 months
Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.	Baseline and Month 6
Change From Baseline to Month 6 in KCCQ Symptom Frequency Score	The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.	Baseline and Month 6

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• McMurray JJ, Anand IS, Diaz R, Maggioni AP, O'Connor C, Pfeffer MA, Polu KR, Solomon SD, Sun Y, Swedberg K, Tendera M, van Veldhuisen DJ, Wasserman SM, Young JB; RED-HF Committees and Investigators. Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity-mortality trial. Eur J Heart Fail. 2009 Aug;11(8):795-801. doi: 10.1093/eurjhf/hfp098. Erratum In: Eur J Heart Fail. 2010 Jul;12(7):765. Pouler, A C [corrected to Pouleur, A C].
• Swedberg K, Young JB, Anand IS, Cheng S, Desai AS, Diaz R, Maggioni AP, McMurray JJ, O'Connor C, Pfeffer MA, Solomon SD, Sun Y, Tendera M, van Veldhuisen DJ; RED-HF Committees; RED-HF Investigators. Treatment of anemia with darbepoetin alfa in systolic heart failure. N Engl J Med. 2013 Mar 28;368(13):1210-9. doi: 10.1056/NEJMoa1214865. Epub 2013 Mar 10.
• Abraityte A, Aukrust P, Kou L, Anand IS, Young J, Mcmurray JJV, van Veldhuisen DJ, Gullestad L, Ueland T. T cell and monocyte/macrophage activation markers associate with adverse outcome, but give limited prognostic value in anemic patients with heart failure: results from RED-HF. Clin Res Cardiol. 2019 Feb;108(2):133-141. doi: 10.1007/s00392-018-1331-2. Epub 2018 Jul 26.
• van der Meer P, Grote Beverborg N, Pfeffer MA, Olson K, Anand IS, Westenbrink BD, McMurray JJV, Swedberg K, Young JB, Solomon SD, van Veldhuisen DJ. Hyporesponsiveness to Darbepoetin Alfa in Patients With Heart Failure and Anemia in the RED-HF Study (Reduction of Events by Darbepoetin Alfa in Heart Failure): Clinical and Prognostic Associations. Circ Heart Fail. 2018 Feb;11(2):e004431. doi: 10.1161/CIRCHEARTFAILURE.117.004431.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2006
• Primary Completion (Actual): October 11, 2012
• Study Completion (Actual): October 11, 2012

Study Registration Dates

• First Submitted: July 27, 2006
• First Submitted That Met QC Criteria: July 27, 2006
• First Posted (Estimate): July 31, 2006

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: patient-reported outcomes; morbidity and mortality; Survival study; heart failure hospitalization; all-cause death; Kansas City Cardiomyopathy questionnaire; anemia treatment
• Additional Relevant MeSH Terms: Heart Diseases; Hematologic Diseases; Heart Failure; Cardiovascular Diseases; Anemia; Ventricular Dysfunction; Hematinics; Darbepoetin alfa
• Other Study ID Numbers: 20050222; RED-HF™ Trial