Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00358215




Registration number
NCT00358215
Ethics application status
Date submitted
27/07/2006
Date registered
31/07/2006
Date last updated
8/11/2022

Titles & IDs
Public title
RED-HFâ„¢ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
Scientific title
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
Secondary ID [1] 0 0
RED-HFâ„¢ Trial
Secondary ID [2] 0 0
20050222
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Anemia 0 0
Cardiovascular Disease 0 0
Ventricular Dysfunction 0 0
Congestive Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darbepoetin alfa
Treatment: Drugs - Placebo

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.

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.


Treatment: Drugs: Darbepoetin alfa
Administered by subcutaneous injection

Treatment: Drugs: Placebo
Placebo subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to All Cause Death or First Hospitalization for Worsening Heart Failure
Timepoint [1] 0 0
From randomization to the end of study; maximum time on study was 73 months
Secondary outcome [1] 0 0
Time to Death From Any Cause
Timepoint [1] 0 0
From randomization to the end of study; maximum time on study was 73 months
Secondary outcome [2] 0 0
Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure
Timepoint [2] 0 0
From randomization to the end of study; maximum time on study was 73 months
Secondary outcome [3] 0 0
Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Timepoint [3] 0 0
Baseline and Month 6
Secondary outcome [4] 0 0
Change From Baseline to Month 6 in KCCQ Symptom Frequency Score
Timepoint [4] 0 0
Baseline and Month 6

Eligibility
Key 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%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/10/2012
Sample size
Target
Accrual to date
Final
2278
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Coffs Harbour
Recruitment hospital [3] 0 0
Research Site - Concord
Recruitment hospital [4] 0 0
Research Site - Gosford
Recruitment hospital [5] 0 0
Research Site - New Lambton Heights
Recruitment hospital [6] 0 0
Research Site - Randwick
Recruitment hospital [7] 0 0
Research Site - Chermside
Recruitment hospital [8] 0 0
Research Site - Kippa Ring
Recruitment hospital [9] 0 0
Research Site - Woolloongabba
Recruitment hospital [10] 0 0
Research Site - Bedford Park
Recruitment hospital [11] 0 0
Research Site - Geelong
Recruitment hospital [12] 0 0
Research Site - Heidelberg
Recruitment hospital [13] 0 0
Research Site - Parkville
Recruitment hospital [14] 0 0
Research Site - Prahran
Recruitment hospital [15] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2250 - Gosford
Recruitment postcode(s) [5] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [6] 0 0
2031 - Randwick
Recruitment postcode(s) [7] 0 0
4032 - Chermside
Recruitment postcode(s) [8] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 0 0
5042 - Bedford Park
Recruitment postcode(s) [11] 0 0
3220 - Geelong
Recruitment postcode(s) [12] 0 0
3084 - Heidelberg
Recruitment postcode(s) [13] 0 0
3052 - Parkville
Recruitment postcode(s) [14] 0 0
3181 - Prahran
Recruitment postcode(s) [15] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Idaho
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Iowa
Country [14] 0 0
United States of America
State/province [14] 0 0
Kansas
Country [15] 0 0
United States of America
State/province [15] 0 0
Kentucky
Country [16] 0 0
United States of America
State/province [16] 0 0
Louisiana
Country [17] 0 0
United States of America
State/province [17] 0 0
Maine
Country [18] 0 0
United States of America
State/province [18] 0 0
Maryland
Country [19] 0 0
United States of America
State/province [19] 0 0
Massachusetts
Country [20] 0 0
United States of America
State/province [20] 0 0
Michigan
Country [21] 0 0
United States of America
State/province [21] 0 0
Minnesota
Country [22] 0 0
United States of America
State/province [22] 0 0
Missouri
Country [23] 0 0
United States of America
State/province [23] 0 0
Montana
Country [24] 0 0
United States of America
State/province [24] 0 0
Nebraska
Country [25] 0 0
United States of America
State/province [25] 0 0
New Hampshire
Country [26] 0 0
United States of America
State/province [26] 0 0
New Jersey
Country [27] 0 0
United States of America
State/province [27] 0 0
New Mexico
Country [28] 0 0
United States of America
State/province [28] 0 0
New York
Country [29] 0 0
United States of America
State/province [29] 0 0
North Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
Ohio
Country [31] 0 0
United States of America
State/province [31] 0 0
Oklahoma
Country [32] 0 0
United States of America
State/province [32] 0 0
Oregon
Country [33] 0 0
United States of America
State/province [33] 0 0
Pennsylvania
Country [34] 0 0
United States of America
State/province [34] 0 0
Rhode Island
Country [35] 0 0
United States of America
State/province [35] 0 0
South Carolina
Country [36] 0 0
United States of America
State/province [36] 0 0
Tennessee
Country [37] 0 0
United States of America
State/province [37] 0 0
Texas
Country [38] 0 0
United States of America
State/province [38] 0 0
Utah
Country [39] 0 0
United States of America
State/province [39] 0 0
Virginia
Country [40] 0 0
United States of America
State/province [40] 0 0
Washington
Country [41] 0 0
United States of America
State/province [41] 0 0
Wisconsin
Country [42] 0 0
Argentina
State/province [42] 0 0
Buenos Aires
Country [43] 0 0
Argentina
State/province [43] 0 0
Córdoba
Country [44] 0 0
Argentina
State/province [44] 0 0
RÃ-o Negro
Country [45] 0 0
Argentina
State/province [45] 0 0
Santa Fe
Country [46] 0 0
Argentina
State/province [46] 0 0
Capital Federal
Country [47] 0 0
Argentina
State/province [47] 0 0
Cordoba
Country [48] 0 0
Argentina
State/province [48] 0 0
Corrientes
Country [49] 0 0
Argentina
State/province [49] 0 0
Mendoza
Country [50] 0 0
Argentina
State/province [50] 0 0
Salta
Country [51] 0 0
Austria
State/province [51] 0 0
Innsbruck
Country [52] 0 0
Austria
State/province [52] 0 0
Linz
Country [53] 0 0
Austria
State/province [53] 0 0
Salzburg
Country [54] 0 0
Austria
State/province [54] 0 0
Wels
Country [55] 0 0
Austria
State/province [55] 0 0
Wien
Country [56] 0 0
Belgium
State/province [56] 0 0
Aalst
Country [57] 0 0
Belgium
State/province [57] 0 0
Antwerpen
Country [58] 0 0
Belgium
State/province [58] 0 0
Bonheiden
Country [59] 0 0
Belgium
State/province [59] 0 0
Brugge
Country [60] 0 0
Belgium
State/province [60] 0 0
Brussel
Country [61] 0 0
Belgium
State/province [61] 0 0
Bruxelles
Country [62] 0 0
Belgium
State/province [62] 0 0
Genk
Country [63] 0 0
Belgium
State/province [63] 0 0
Gent
Country [64] 0 0
Belgium
State/province [64] 0 0
Hasselt
Country [65] 0 0
Belgium
State/province [65] 0 0
Huy
Country [66] 0 0
Belgium
State/province [66] 0 0
Leuven
Country [67] 0 0
Belgium
State/province [67] 0 0
Roeselare
Country [68] 0 0
Belgium
State/province [68] 0 0
Turnhout
Country [69] 0 0
Brazil
State/province [69] 0 0
Bahia
Country [70] 0 0
Brazil
State/province [70] 0 0
Ceará
Country [71] 0 0
Brazil
State/province [71] 0 0
Goiás
Country [72] 0 0
Brazil
State/province [72] 0 0
Minas Gerais
Country [73] 0 0
Brazil
State/province [73] 0 0
Paraná
Country [74] 0 0
Brazil
State/province [74] 0 0
Pernambuco
Country [75] 0 0
Brazil
State/province [75] 0 0
Rio Grande Do Sul
Country [76] 0 0
Brazil
State/province [76] 0 0
São Paulo
Country [77] 0 0
Brazil
State/province [77] 0 0
Rio de Janeiro
Country [78] 0 0
Brazil
State/province [78] 0 0
Rio De Janeiro
Country [79] 0 0
Bulgaria
State/province [79] 0 0
Dimitrovgrad
Country [80] 0 0
Bulgaria
State/province [80] 0 0
Haskovo
Country [81] 0 0
Bulgaria
State/province [81] 0 0
Pleven
Country [82] 0 0
Bulgaria
State/province [82] 0 0
Plovdiv
Country [83] 0 0
Bulgaria
State/province [83] 0 0
Rouse
Country [84] 0 0
Bulgaria
State/province [84] 0 0
Sofia
Country [85] 0 0
Bulgaria
State/province [85] 0 0
Varna
Country [86] 0 0
Bulgaria
State/province [86] 0 0
Veliko Tarnovo
Country [87] 0 0
Canada
State/province [87] 0 0
Alberta
Country [88] 0 0
Canada
State/province [88] 0 0
British Columbia
Country [89] 0 0
Canada
State/province [89] 0 0
Manitoba
Country [90] 0 0
Canada
State/province [90] 0 0
Newfoundland and Labrador
Country [91] 0 0
Canada
State/province [91] 0 0
Nova Scotia
Country [92] 0 0
Canada
State/province [92] 0 0
Ontario
Country [93] 0 0
Canada
State/province [93] 0 0
Quebec
Country [94] 0 0
Canada
State/province [94] 0 0
Saskatchewan
Country [95] 0 0
Chile
State/province [95] 0 0
Cachapoal
Country [96] 0 0
Chile
State/province [96] 0 0
Elqui
Country [97] 0 0
Chile
State/province [97] 0 0
Santiago
Country [98] 0 0
Chile
State/province [98] 0 0
Osorno
Country [99] 0 0
Chile
State/province [99] 0 0
Temuco
Country [100] 0 0
Chile
State/province [100] 0 0
Vina del Mar
Country [101] 0 0
Czechia
State/province [101] 0 0
Benesov
Country [102] 0 0
Czechia
State/province [102] 0 0
Brno
Country [103] 0 0
Czechia
State/province [103] 0 0
Ceske Budejovice
Country [104] 0 0
Czechia
State/province [104] 0 0
Jihlava
Country [105] 0 0
Czechia
State/province [105] 0 0
Karlovy Vary
Country [106] 0 0
Czechia
State/province [106] 0 0
Pardubice
Country [107] 0 0
Czechia
State/province [107] 0 0
Praha 10
Country [108] 0 0
Czechia
State/province [108] 0 0
Praha 1
Country [109] 0 0
Czechia
State/province [109] 0 0
Praha 2
Country [110] 0 0
Czechia
State/province [110] 0 0
Pribram 8
Country [111] 0 0
Czechia
State/province [111] 0 0
Tabor
Country [112] 0 0
Czechia
State/province [112] 0 0
Usti nad Labem
Country [113] 0 0
Denmark
State/province [113] 0 0
Fredericia
Country [114] 0 0
Denmark
State/province [114] 0 0
Frederiksberg
Country [115] 0 0
Denmark
State/province [115] 0 0
Frederikshavn
Country [116] 0 0
Denmark
State/province [116] 0 0
Glostrup
Country [117] 0 0
Denmark
State/province [117] 0 0
Hellerup
Country [118] 0 0
Denmark
State/province [118] 0 0
Herlev
Country [119] 0 0
Denmark
State/province [119] 0 0
Horsens
Country [120] 0 0
Denmark
State/province [120] 0 0
Hvidovre
Country [121] 0 0
Denmark
State/province [121] 0 0
København S
Country [122] 0 0
Denmark
State/province [122] 0 0
København ÃËœ
Country [123] 0 0
Denmark
State/province [123] 0 0
Køge
Country [124] 0 0
Denmark
State/province [124] 0 0
Odense
Country [125] 0 0
Denmark
State/province [125] 0 0
Roskilde
Country [126] 0 0
Denmark
State/province [126] 0 0
Svendborg
Country [127] 0 0
Estonia
State/province [127] 0 0
Pärnu
Country [128] 0 0
Estonia
State/province [128] 0 0
Tallinn
Country [129] 0 0
Finland
State/province [129] 0 0
Espoo
Country [130] 0 0
Finland
State/province [130] 0 0
Helsinki
Country [131] 0 0
Finland
State/province [131] 0 0
Lahti
Country [132] 0 0
Finland
State/province [132] 0 0
Seinajoki
Country [133] 0 0
France
State/province [133] 0 0
Bron
Country [134] 0 0
France
State/province [134] 0 0
Caen Cedex 14
Country [135] 0 0
France
State/province [135] 0 0
Cholet Cedex
Country [136] 0 0
France
State/province [136] 0 0
Créteil Cedex
Country [137] 0 0
France
State/province [137] 0 0
Douai Cedex
Country [138] 0 0
France
State/province [138] 0 0
Grenoble Cedex 9
Country [139] 0 0
France
State/province [139] 0 0
Lille Cedex
Country [140] 0 0
France
State/province [140] 0 0
Montfermeil
Country [141] 0 0
France
State/province [141] 0 0
Montpellier cedex 05
Country [142] 0 0
France
State/province [142] 0 0
Nice Cedex 01
Country [143] 0 0
France
State/province [143] 0 0
Paris Cedex 13
Country [144] 0 0
France
State/province [144] 0 0
Paris
Country [145] 0 0
France
State/province [145] 0 0
Pessac Cedex
Country [146] 0 0
France
State/province [146] 0 0
Poitiers
Country [147] 0 0
France
State/province [147] 0 0
Pontoise Cedex
Country [148] 0 0
France
State/province [148] 0 0
Rouen Cedex
Country [149] 0 0
France
State/province [149] 0 0
Saint Herblain
Country [150] 0 0
France
State/province [150] 0 0
Strasbourg
Country [151] 0 0
France
State/province [151] 0 0
Toulouse Cedex 09
Country [152] 0 0
France
State/province [152] 0 0
Vandoeuvre-les-Nancy
Country [153] 0 0
Germany
State/province [153] 0 0
Bad Tölz
Country [154] 0 0
Germany
State/province [154] 0 0
Berlin
Country [155] 0 0
Germany
State/province [155] 0 0
Bochum
Country [156] 0 0
Germany
State/province [156] 0 0
Bremen
Country [157] 0 0
Germany
State/province [157] 0 0
Frankfurt
Country [158] 0 0
Germany
State/province [158] 0 0
Georgsmarienhütte
Country [159] 0 0
Germany
State/province [159] 0 0
Göttingen
Country [160] 0 0
Germany
State/province [160] 0 0
Hamburg
Country [161] 0 0
Germany
State/province [161] 0 0
Hannover
Country [162] 0 0
Germany
State/province [162] 0 0
Heidelberg
Country [163] 0 0
Germany
State/province [163] 0 0
Homburg
Country [164] 0 0
Germany
State/province [164] 0 0
Ingelheim
Country [165] 0 0
Germany
State/province [165] 0 0
Köln
Country [166] 0 0
Germany
State/province [166] 0 0
Lahr
Country [167] 0 0
Germany
State/province [167] 0 0
Leipzig
Country [168] 0 0
Germany
State/province [168] 0 0
Mainz
Country [169] 0 0
Germany
State/province [169] 0 0
Marburg
Country [170] 0 0
Germany
State/province [170] 0 0
Nürnberg
Country [171] 0 0
Germany
State/province [171] 0 0
Schwedt
Country [172] 0 0
Germany
State/province [172] 0 0
Stuttgart
Country [173] 0 0
Germany
State/province [173] 0 0
Witten
Country [174] 0 0
Hong Kong
State/province [174] 0 0
Hong Kong
Country [175] 0 0
Hong Kong
State/province [175] 0 0
New Territories
Country [176] 0 0
Hungary
State/province [176] 0 0
Bekescsaba
Country [177] 0 0
Hungary
State/province [177] 0 0
Budapest
Country [178] 0 0
Hungary
State/province [178] 0 0
Debrecen
Country [179] 0 0
Hungary
State/province [179] 0 0
Gyor
Country [180] 0 0
Hungary
State/province [180] 0 0
Kalocsa
Country [181] 0 0
Hungary
State/province [181] 0 0
Kecskemet
Country [182] 0 0
Hungary
State/province [182] 0 0
Sopron
Country [183] 0 0
Hungary
State/province [183] 0 0
Szeged
Country [184] 0 0
Hungary
State/province [184] 0 0
Szekesfehervar
Country [185] 0 0
Hungary
State/province [185] 0 0
Szekszard
Country [186] 0 0
Hungary
State/province [186] 0 0
Szolnok
Country [187] 0 0
Hungary
State/province [187] 0 0
Veszprem
Country [188] 0 0
Hungary
State/province [188] 0 0
Zalaegerszeg
Country [189] 0 0
India
State/province [189] 0 0
Andhra Pradesh
Country [190] 0 0
India
State/province [190] 0 0
Delhi
Country [191] 0 0
India
State/province [191] 0 0
Gujarat
Country [192] 0 0
India
State/province [192] 0 0
Haryana
Country [193] 0 0
India
State/province [193] 0 0
Karnataka
Country [194] 0 0
India
State/province [194] 0 0
Maharashtra
Country [195] 0 0
India
State/province [195] 0 0
Punjab
Country [196] 0 0
India
State/province [196] 0 0
Rajasthan
Country [197] 0 0
India
State/province [197] 0 0
Tamil Nadu
Country [198] 0 0
India
State/province [198] 0 0
Uttar Pradesh
Country [199] 0 0
India
State/province [199] 0 0
Mumbai
Country [200] 0 0
Israel
State/province [200] 0 0
Askelon
Country [201] 0 0
Israel
State/province [201] 0 0
Beer Sheva
Country [202] 0 0
Israel
State/province [202] 0 0
Beer Yaakov
Country [203] 0 0
Israel
State/province [203] 0 0
Givatayim
Country [204] 0 0
Israel
State/province [204] 0 0
Hadera
Country [205] 0 0
Israel
State/province [205] 0 0
Haifa
Country [206] 0 0
Israel
State/province [206] 0 0
Holon
Country [207] 0 0
Israel
State/province [207] 0 0
Jerusalem
Country [208] 0 0
Israel
State/province [208] 0 0
Kfar Saba
Country [209] 0 0
Israel
State/province [209] 0 0
Safed
Country [210] 0 0
Israel
State/province [210] 0 0
Tel-Aviv
Country [211] 0 0
Italy
State/province [211] 0 0
Arezzo
Country [212] 0 0
Italy
State/province [212] 0 0
Bergamo
Country [213] 0 0
Italy
State/province [213] 0 0
Cesenatico (FC)
Country [214] 0 0
Italy
State/province [214] 0 0
Cetraro CS
Country [215] 0 0
Italy
State/province [215] 0 0
Cortona AR
Country [216] 0 0
Italy
State/province [216] 0 0
Eboli
Country [217] 0 0
Italy
State/province [217] 0 0
Ferrara
Country [218] 0 0
Italy
State/province [218] 0 0
Forlì
Country [219] 0 0
Italy
State/province [219] 0 0
Milano
Country [220] 0 0
Italy
State/province [220] 0 0
Napoli
Country [221] 0 0
Italy
State/province [221] 0 0
Oliveto Citra SA
Country [222] 0 0
Italy
State/province [222] 0 0
Palermo
Country [223] 0 0
Italy
State/province [223] 0 0
Palmanova UD
Country [224] 0 0
Italy
State/province [224] 0 0
Pavia
Country [225] 0 0
Italy
State/province [225] 0 0
Roma
Country [226] 0 0
Italy
State/province [226] 0 0
Rozzano MI
Country [227] 0 0
Italy
State/province [227] 0 0
San Bonifacio VR
Country [228] 0 0
Italy
State/province [228] 0 0
Torino
Country [229] 0 0
Italy
State/province [229] 0 0
Trento
Country [230] 0 0
Italy
State/province [230] 0 0
Udine
Country [231] 0 0
Latvia
State/province [231] 0 0
Daugavpils
Country [232] 0 0
Latvia
State/province [232] 0 0
Ogre
Country [233] 0 0
Latvia
State/province [233] 0 0
Rezekne
Country [234] 0 0
Latvia
State/province [234] 0 0
Riga
Country [235] 0 0
Lithuania
State/province [235] 0 0
Alytus
Country [236] 0 0
Lithuania
State/province [236] 0 0
Kaunas
Country [237] 0 0
Lithuania
State/province [237] 0 0
Klaipeda
Country [238] 0 0
Lithuania
State/province [238] 0 0
Siauliai
Country [239] 0 0
Lithuania
State/province [239] 0 0
Vilnius
Country [240] 0 0
Mexico
State/province [240] 0 0
Distrito Federal
Country [241] 0 0
Mexico
State/province [241] 0 0
Jalisco
Country [242] 0 0
Mexico
State/province [242] 0 0
Nuevo León
Country [243] 0 0
Mexico
State/province [243] 0 0
San Luis PotosÃ-
Country [244] 0 0
Mexico
State/province [244] 0 0
Veracruz
Country [245] 0 0
Mexico
State/province [245] 0 0
Yucatán
Country [246] 0 0
Mexico
State/province [246] 0 0
Baja California
Country [247] 0 0
Netherlands
State/province [247] 0 0
's Hertogenbosch
Country [248] 0 0
Netherlands
State/province [248] 0 0
Alkmaar
Country [249] 0 0
Netherlands
State/province [249] 0 0
Almelo
Country [250] 0 0
Netherlands
State/province [250] 0 0
Amsterdam
Country [251] 0 0
Netherlands
State/province [251] 0 0
Arnhem
Country [252] 0 0
Netherlands
State/province [252] 0 0
Assen
Country [253] 0 0
Netherlands
State/province [253] 0 0
Blaricum
Country [254] 0 0
Netherlands
State/province [254] 0 0
Breda
Country [255] 0 0
Netherlands
State/province [255] 0 0
Delft
Country [256] 0 0
Netherlands
State/province [256] 0 0
Den Haag
Country [257] 0 0
Netherlands
State/province [257] 0 0
Deventer
Country [258] 0 0
Netherlands
State/province [258] 0 0
Eindhoven
Country [259] 0 0
Netherlands
State/province [259] 0 0
Enschede
Country [260] 0 0
Netherlands
State/province [260] 0 0
Groningen
Country [261] 0 0
Netherlands
State/province [261] 0 0
Haarlem
Country [262] 0 0
Netherlands
State/province [262] 0 0
Harderwijk
Country [263] 0 0
Netherlands
State/province [263] 0 0
Heerlen
Country [264] 0 0
Netherlands
State/province [264] 0 0
Hilversum
Country [265] 0 0
Netherlands
State/province [265] 0 0
Hoorn
Country [266] 0 0
Netherlands
State/province [266] 0 0
Nijmegen
Country [267] 0 0
Netherlands
State/province [267] 0 0
Rotterdam
Country [268] 0 0
Netherlands
State/province [268] 0 0
Sneek
Country [269] 0 0
Netherlands
State/province [269] 0 0
Tiel
Country [270] 0 0
Netherlands
State/province [270] 0 0
Tilburg
Country [271] 0 0
Netherlands
State/province [271] 0 0
Zwijndrecht
Country [272] 0 0
Norway
State/province [272] 0 0
Arendal
Country [273] 0 0
Norway
State/province [273] 0 0
Gjettum
Country [274] 0 0
Norway
State/province [274] 0 0
Kristiansand
Country [275] 0 0
Norway
State/province [275] 0 0
Oslo
Country [276] 0 0
Norway
State/province [276] 0 0
Skien
Country [277] 0 0
Norway
State/province [277] 0 0
Stavanger
Country [278] 0 0
Norway
State/province [278] 0 0
Ã…lesund
Country [279] 0 0
Poland
State/province [279] 0 0
Bialystok
Country [280] 0 0
Poland
State/province [280] 0 0
Gdansk
Country [281] 0 0
Poland
State/province [281] 0 0
Gdynia
Country [282] 0 0
Poland
State/province [282] 0 0
Katowice
Country [283] 0 0
Poland
State/province [283] 0 0
Krakow
Country [284] 0 0
Poland
State/province [284] 0 0
Lublin
Country [285] 0 0
Poland
State/province [285] 0 0
Stalowa Wola
Country [286] 0 0
Poland
State/province [286] 0 0
Tarnow
Country [287] 0 0
Poland
State/province [287] 0 0
Walbrzych
Country [288] 0 0
Poland
State/province [288] 0 0
Warszawa
Country [289] 0 0
Poland
State/province [289] 0 0
Wroclaw
Country [290] 0 0
Poland
State/province [290] 0 0
Zabrze
Country [291] 0 0
Poland
State/province [291] 0 0
Zielona Gora
Country [292] 0 0
Portugal
State/province [292] 0 0
Coimbra
Country [293] 0 0
Portugal
State/province [293] 0 0
Faro
Country [294] 0 0
Portugal
State/province [294] 0 0
Lisboa
Country [295] 0 0
Portugal
State/province [295] 0 0
Lisbon
Country [296] 0 0
Puerto Rico
State/province [296] 0 0
San Juan
Country [297] 0 0
Romania
State/province [297] 0 0
Arad
Country [298] 0 0
Romania
State/province [298] 0 0
Bacau
Country [299] 0 0
Romania
State/province [299] 0 0
Brasov
Country [300] 0 0
Romania
State/province [300] 0 0
Bucuresti
Country [301] 0 0
Romania
State/province [301] 0 0
Iasi
Country [302] 0 0
Romania
State/province [302] 0 0
Oradea
Country [303] 0 0
Romania
State/province [303] 0 0
Sibiu
Country [304] 0 0
Romania
State/province [304] 0 0
Targu Mures
Country [305] 0 0
Romania
State/province [305] 0 0
Timisoara
Country [306] 0 0
Russian Federation
State/province [306] 0 0
Moscow
Country [307] 0 0
Russian Federation
State/province [307] 0 0
Saint Petersburg
Country [308] 0 0
Russian Federation
State/province [308] 0 0
Sankt-Petersburg
Country [309] 0 0
Russian Federation
State/province [309] 0 0
St Petersburg
Country [310] 0 0
Russian Federation
State/province [310] 0 0
St. Petersburg
Country [311] 0 0
Russian Federation
State/province [311] 0 0
Volgograd
Country [312] 0 0
Slovakia
State/province [312] 0 0
Bardejov
Country [313] 0 0
Slovakia
State/province [313] 0 0
Bratislava
Country [314] 0 0
Slovakia
State/province [314] 0 0
Kosice
Country [315] 0 0
Slovakia
State/province [315] 0 0
Levice
Country [316] 0 0
Slovakia
State/province [316] 0 0
Lucenec
Country [317] 0 0
Slovakia
State/province [317] 0 0
Nitra
Country [318] 0 0
Slovakia
State/province [318] 0 0
Presov
Country [319] 0 0
Slovakia
State/province [319] 0 0
Zilina
Country [320] 0 0
South Africa
State/province [320] 0 0
Gauteng
Country [321] 0 0
South Africa
State/province [321] 0 0
KwaZulu-Natal
Country [322] 0 0
South Africa
State/province [322] 0 0
Western Cape
Country [323] 0 0
South Africa
State/province [323] 0 0
Cape Town
Country [324] 0 0
Spain
State/province [324] 0 0
AndalucÃ-a
Country [325] 0 0
Spain
State/province [325] 0 0
Asturias
Country [326] 0 0
Spain
State/province [326] 0 0
Cantabria
Country [327] 0 0
Spain
State/province [327] 0 0
Cataluña
Country [328] 0 0
Spain
State/province [328] 0 0
Comunidad Valenciana
Country [329] 0 0
Spain
State/province [329] 0 0
Galicia
Country [330] 0 0
Spain
State/province [330] 0 0
Madrid
Country [331] 0 0
Spain
State/province [331] 0 0
Murcia
Country [332] 0 0
Spain
State/province [332] 0 0
PaÃ-s Vasco
Country [333] 0 0
Sweden
State/province [333] 0 0
Danderyd
Country [334] 0 0
Sweden
State/province [334] 0 0
Göteborg
Country [335] 0 0
Sweden
State/province [335] 0 0
Linköping
Country [336] 0 0
Sweden
State/province [336] 0 0
Malmö
Country [337] 0 0
Sweden
State/province [337] 0 0
Mölndal
Country [338] 0 0
Sweden
State/province [338] 0 0
Stockholm
Country [339] 0 0
Sweden
State/province [339] 0 0
Sundsvall
Country [340] 0 0
Sweden
State/province [340] 0 0
Umeå
Country [341] 0 0
Sweden
State/province [341] 0 0
Uppsala
Country [342] 0 0
Sweden
State/province [342] 0 0
Ã-rebro
Country [343] 0 0
Switzerland
State/province [343] 0 0
Lugano
Country [344] 0 0
Switzerland
State/province [344] 0 0
St. Gallen
Country [345] 0 0
United Kingdom
State/province [345] 0 0
Barnet
Country [346] 0 0
United Kingdom
State/province [346] 0 0
Belfast
Country [347] 0 0
United Kingdom
State/province [347] 0 0
Birmingham
Country [348] 0 0
United Kingdom
State/province [348] 0 0
Bradford
Country [349] 0 0
United Kingdom
State/province [349] 0 0
Bridlington
Country [350] 0 0
United Kingdom
State/province [350] 0 0
Cottingham
Country [351] 0 0
United Kingdom
State/province [351] 0 0
Coventry
Country [352] 0 0
United Kingdom
State/province [352] 0 0
Glasgow
Country [353] 0 0
United Kingdom
State/province [353] 0 0
Harrow
Country [354] 0 0
United Kingdom
State/province [354] 0 0
Kirkcaldy
Country [355] 0 0
United Kingdom
State/province [355] 0 0
Leeds
Country [356] 0 0
United Kingdom
State/province [356] 0 0
Leicester
Country [357] 0 0
United Kingdom
State/province [357] 0 0
Livingston
Country [358] 0 0
United Kingdom
State/province [358] 0 0
London
Country [359] 0 0
United Kingdom
State/province [359] 0 0
Manchester
Country [360] 0 0
United Kingdom
State/province [360] 0 0
Romford
Country [361] 0 0
United Kingdom
State/province [361] 0 0
Stockport
Country [362] 0 0
United Kingdom
State/province [362] 0 0
Worcester
Country [363] 0 0
United Kingdom
State/province [363] 0 0
Worthing
Country [364] 0 0
United Kingdom
State/province [364] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00358215
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00358215