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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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RED-HFâ„¢ Trial
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Secondary ID [2]
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20050222
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Anemia
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Cardiovascular Disease
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0
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Ventricular Dysfunction
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Congestive Heart Failure
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0
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Condition category
Condition code
Cardiovascular
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0
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0
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Coronary heart disease
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Cardiovascular
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0
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Other cardiovascular diseases
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Blood
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0
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Anaemia
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to All Cause Death or First Hospitalization for Worsening Heart Failure
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Assessment method [1]
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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.
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Timepoint [1]
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From randomization to the end of study; maximum time on study was 73 months
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Secondary outcome [1]
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Time to Death From Any Cause
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Assessment method [1]
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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.
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Timepoint [1]
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From randomization to the end of study; maximum time on study was 73 months
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Secondary outcome [2]
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Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure
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Assessment method [2]
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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.
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Timepoint [2]
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From randomization to the end of study; maximum time on study was 73 months
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Secondary outcome [3]
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Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and Month 6
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Secondary outcome [4]
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Change From Baseline to Month 6 in KCCQ Symptom Frequency Score
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline and Month 6
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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%
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/10/2012
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Sample size
Target
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Accrual to date
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Final
2278
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Research Site - Camperdown
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2050 - Camperdown
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2450 - Coffs Harbour
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2139 - Concord
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2250 - Gosford
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2305 - New Lambton Heights
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2031 - Randwick
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4032 - Chermside
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4021 - Kippa Ring
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4102 - Woolloongabba
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5042 - Bedford Park
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3220 - Geelong
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3084 - Heidelberg
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3052 - Parkville
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3181 - Prahran
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Recruitment postcode(s) [15]
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6009 - Nedlands
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Recruitment outside Australia
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State/province [110]
0
0
Pribram 8
Query!
Country [111]
0
0
Czechia
Query!
State/province [111]
0
0
Tabor
Query!
Country [112]
0
0
Czechia
Query!
State/province [112]
0
0
Usti nad Labem
Query!
Country [113]
0
0
Denmark
Query!
State/province [113]
0
0
Fredericia
Query!
Country [114]
0
0
Denmark
Query!
State/province [114]
0
0
Frederiksberg
Query!
Country [115]
0
0
Denmark
Query!
State/province [115]
0
0
Frederikshavn
Query!
Country [116]
0
0
Denmark
Query!
State/province [116]
0
0
Glostrup
Query!
Country [117]
0
0
Denmark
Query!
State/province [117]
0
0
Hellerup
Query!
Country [118]
0
0
Denmark
Query!
State/province [118]
0
0
Herlev
Query!
Country [119]
0
0
Denmark
Query!
State/province [119]
0
0
Horsens
Query!
Country [120]
0
0
Denmark
Query!
State/province [120]
0
0
Hvidovre
Query!
Country [121]
0
0
Denmark
Query!
State/province [121]
0
0
København S
Query!
Country [122]
0
0
Denmark
Query!
State/province [122]
0
0
København ÃËœ
Query!
Country [123]
0
0
Denmark
Query!
State/province [123]
0
0
Køge
Query!
Country [124]
0
0
Denmark
Query!
State/province [124]
0
0
Odense
Query!
Country [125]
0
0
Denmark
Query!
State/province [125]
0
0
Roskilde
Query!
Country [126]
0
0
Denmark
Query!
State/province [126]
0
0
Svendborg
Query!
Country [127]
0
0
Estonia
Query!
State/province [127]
0
0
Pärnu
Query!
Country [128]
0
0
Estonia
Query!
State/province [128]
0
0
Tallinn
Query!
Country [129]
0
0
Finland
Query!
State/province [129]
0
0
Espoo
Query!
Country [130]
0
0
Finland
Query!
State/province [130]
0
0
Helsinki
Query!
Country [131]
0
0
Finland
Query!
State/province [131]
0
0
Lahti
Query!
Country [132]
0
0
Finland
Query!
State/province [132]
0
0
Seinajoki
Query!
Country [133]
0
0
France
Query!
State/province [133]
0
0
Bron
Query!
Country [134]
0
0
France
Query!
State/province [134]
0
0
Caen Cedex 14
Query!
Country [135]
0
0
France
Query!
State/province [135]
0
0
Cholet Cedex
Query!
Country [136]
0
0
France
Query!
State/province [136]
0
0
Créteil Cedex
Query!
Country [137]
0
0
France
Query!
State/province [137]
0
0
Douai Cedex
Query!
Country [138]
0
0
France
Query!
State/province [138]
0
0
Grenoble Cedex 9
Query!
Country [139]
0
0
France
Query!
State/province [139]
0
0
Lille Cedex
Query!
Country [140]
0
0
France
Query!
State/province [140]
0
0
Montfermeil
Query!
Country [141]
0
0
France
Query!
State/province [141]
0
0
Montpellier cedex 05
Query!
Country [142]
0
0
France
Query!
State/province [142]
0
0
Nice Cedex 01
Query!
Country [143]
0
0
France
Query!
State/province [143]
0
0
Paris Cedex 13
Query!
Country [144]
0
0
France
Query!
State/province [144]
0
0
Paris
Query!
Country [145]
0
0
France
Query!
State/province [145]
0
0
Pessac Cedex
Query!
Country [146]
0
0
France
Query!
State/province [146]
0
0
Poitiers
Query!
Country [147]
0
0
France
Query!
State/province [147]
0
0
Pontoise Cedex
Query!
Country [148]
0
0
France
Query!
State/province [148]
0
0
Rouen Cedex
Query!
Country [149]
0
0
France
Query!
State/province [149]
0
0
Saint Herblain
Query!
Country [150]
0
0
France
Query!
State/province [150]
0
0
Strasbourg
Query!
Country [151]
0
0
France
Query!
State/province [151]
0
0
Toulouse Cedex 09
Query!
Country [152]
0
0
France
Query!
State/province [152]
0
0
Vandoeuvre-les-Nancy
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Bad Tölz
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Berlin
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Bochum
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Bremen
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Frankfurt
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Georgsmarienhütte
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Göttingen
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Hamburg
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Hannover
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Heidelberg
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Homburg
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Ingelheim
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Köln
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Lahr
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Leipzig
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Mainz
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Marburg
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Nürnberg
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Schwedt
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Stuttgart
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Witten
Query!
Country [174]
0
0
Hong Kong
Query!
State/province [174]
0
0
Hong Kong
Query!
Country [175]
0
0
Hong Kong
Query!
State/province [175]
0
0
New Territories
Query!
Country [176]
0
0
Hungary
Query!
State/province [176]
0
0
Bekescsaba
Query!
Country [177]
0
0
Hungary
Query!
State/province [177]
0
0
Budapest
Query!
Country [178]
0
0
Hungary
Query!
State/province [178]
0
0
Debrecen
Query!
Country [179]
0
0
Hungary
Query!
State/province [179]
0
0
Gyor
Query!
Country [180]
0
0
Hungary
Query!
State/province [180]
0
0
Kalocsa
Query!
Country [181]
0
0
Hungary
Query!
State/province [181]
0
0
Kecskemet
Query!
Country [182]
0
0
Hungary
Query!
State/province [182]
0
0
Sopron
Query!
Country [183]
0
0
Hungary
Query!
State/province [183]
0
0
Szeged
Query!
Country [184]
0
0
Hungary
Query!
State/province [184]
0
0
Szekesfehervar
Query!
Country [185]
0
0
Hungary
Query!
State/province [185]
0
0
Szekszard
Query!
Country [186]
0
0
Hungary
Query!
State/province [186]
0
0
Szolnok
Query!
Country [187]
0
0
Hungary
Query!
State/province [187]
0
0
Veszprem
Query!
Country [188]
0
0
Hungary
Query!
State/province [188]
0
0
Zalaegerszeg
Query!
Country [189]
0
0
India
Query!
State/province [189]
0
0
Andhra Pradesh
Query!
Country [190]
0
0
India
Query!
State/province [190]
0
0
Delhi
Query!
Country [191]
0
0
India
Query!
State/province [191]
0
0
Gujarat
Query!
Country [192]
0
0
India
Query!
State/province [192]
0
0
Haryana
Query!
Country [193]
0
0
India
Query!
State/province [193]
0
0
Karnataka
Query!
Country [194]
0
0
India
Query!
State/province [194]
0
0
Maharashtra
Query!
Country [195]
0
0
India
Query!
State/province [195]
0
0
Punjab
Query!
Country [196]
0
0
India
Query!
State/province [196]
0
0
Rajasthan
Query!
Country [197]
0
0
India
Query!
State/province [197]
0
0
Tamil Nadu
Query!
Country [198]
0
0
India
Query!
State/province [198]
0
0
Uttar Pradesh
Query!
Country [199]
0
0
India
Query!
State/province [199]
0
0
Mumbai
Query!
Country [200]
0
0
Israel
Query!
State/province [200]
0
0
Askelon
Query!
Country [201]
0
0
Israel
Query!
State/province [201]
0
0
Beer Sheva
Query!
Country [202]
0
0
Israel
Query!
State/province [202]
0
0
Beer Yaakov
Query!
Country [203]
0
0
Israel
Query!
State/province [203]
0
0
Givatayim
Query!
Country [204]
0
0
Israel
Query!
State/province [204]
0
0
Hadera
Query!
Country [205]
0
0
Israel
Query!
State/province [205]
0
0
Haifa
Query!
Country [206]
0
0
Israel
Query!
State/province [206]
0
0
Holon
Query!
Country [207]
0
0
Israel
Query!
State/province [207]
0
0
Jerusalem
Query!
Country [208]
0
0
Israel
Query!
State/province [208]
0
0
Kfar Saba
Query!
Country [209]
0
0
Israel
Query!
State/province [209]
0
0
Safed
Query!
Country [210]
0
0
Israel
Query!
State/province [210]
0
0
Tel-Aviv
Query!
Country [211]
0
0
Italy
Query!
State/province [211]
0
0
Arezzo
Query!
Country [212]
0
0
Italy
Query!
State/province [212]
0
0
Bergamo
Query!
Country [213]
0
0
Italy
Query!
State/province [213]
0
0
Cesenatico (FC)
Query!
Country [214]
0
0
Italy
Query!
State/province [214]
0
0
Cetraro CS
Query!
Country [215]
0
0
Italy
Query!
State/province [215]
0
0
Cortona AR
Query!
Country [216]
0
0
Italy
Query!
State/province [216]
0
0
Eboli
Query!
Country [217]
0
0
Italy
Query!
State/province [217]
0
0
Ferrara
Query!
Country [218]
0
0
Italy
Query!
State/province [218]
0
0
Forlì
Query!
Country [219]
0
0
Italy
Query!
State/province [219]
0
0
Milano
Query!
Country [220]
0
0
Italy
Query!
State/province [220]
0
0
Napoli
Query!
Country [221]
0
0
Italy
Query!
State/province [221]
0
0
Oliveto Citra SA
Query!
Country [222]
0
0
Italy
Query!
State/province [222]
0
0
Palermo
Query!
Country [223]
0
0
Italy
Query!
State/province [223]
0
0
Palmanova UD
Query!
Country [224]
0
0
Italy
Query!
State/province [224]
0
0
Pavia
Query!
Country [225]
0
0
Italy
Query!
State/province [225]
0
0
Roma
Query!
Country [226]
0
0
Italy
Query!
State/province [226]
0
0
Rozzano MI
Query!
Country [227]
0
0
Italy
Query!
State/province [227]
0
0
San Bonifacio VR
Query!
Country [228]
0
0
Italy
Query!
State/province [228]
0
0
Torino
Query!
Country [229]
0
0
Italy
Query!
State/province [229]
0
0
Trento
Query!
Country [230]
0
0
Italy
Query!
State/province [230]
0
0
Udine
Query!
Country [231]
0
0
Latvia
Query!
State/province [231]
0
0
Daugavpils
Query!
Country [232]
0
0
Latvia
Query!
State/province [232]
0
0
Ogre
Query!
Country [233]
0
0
Latvia
Query!
State/province [233]
0
0
Rezekne
Query!
Country [234]
0
0
Latvia
Query!
State/province [234]
0
0
Riga
Query!
Country [235]
0
0
Lithuania
Query!
State/province [235]
0
0
Alytus
Query!
Country [236]
0
0
Lithuania
Query!
State/province [236]
0
0
Kaunas
Query!
Country [237]
0
0
Lithuania
Query!
State/province [237]
0
0
Klaipeda
Query!
Country [238]
0
0
Lithuania
Query!
State/province [238]
0
0
Siauliai
Query!
Country [239]
0
0
Lithuania
Query!
State/province [239]
0
0
Vilnius
Query!
Country [240]
0
0
Mexico
Query!
State/province [240]
0
0
Distrito Federal
Query!
Country [241]
0
0
Mexico
Query!
State/province [241]
0
0
Jalisco
Query!
Country [242]
0
0
Mexico
Query!
State/province [242]
0
0
Nuevo León
Query!
Country [243]
0
0
Mexico
Query!
State/province [243]
0
0
San Luis PotosÃ-
Query!
Country [244]
0
0
Mexico
Query!
State/province [244]
0
0
Veracruz
Query!
Country [245]
0
0
Mexico
Query!
State/province [245]
0
0
Yucatán
Query!
Country [246]
0
0
Mexico
Query!
State/province [246]
0
0
Baja California
Query!
Country [247]
0
0
Netherlands
Query!
State/province [247]
0
0
's Hertogenbosch
Query!
Country [248]
0
0
Netherlands
Query!
State/province [248]
0
0
Alkmaar
Query!
Country [249]
0
0
Netherlands
Query!
State/province [249]
0
0
Almelo
Query!
Country [250]
0
0
Netherlands
Query!
State/province [250]
0
0
Amsterdam
Query!
Country [251]
0
0
Netherlands
Query!
State/province [251]
0
0
Arnhem
Query!
Country [252]
0
0
Netherlands
Query!
State/province [252]
0
0
Assen
Query!
Country [253]
0
0
Netherlands
Query!
State/province [253]
0
0
Blaricum
Query!
Country [254]
0
0
Netherlands
Query!
State/province [254]
0
0
Breda
Query!
Country [255]
0
0
Netherlands
Query!
State/province [255]
0
0
Delft
Query!
Country [256]
0
0
Netherlands
Query!
State/province [256]
0
0
Den Haag
Query!
Country [257]
0
0
Netherlands
Query!
State/province [257]
0
0
Deventer
Query!
Country [258]
0
0
Netherlands
Query!
State/province [258]
0
0
Eindhoven
Query!
Country [259]
0
0
Netherlands
Query!
State/province [259]
0
0
Enschede
Query!
Country [260]
0
0
Netherlands
Query!
State/province [260]
0
0
Groningen
Query!
Country [261]
0
0
Netherlands
Query!
State/province [261]
0
0
Haarlem
Query!
Country [262]
0
0
Netherlands
Query!
State/province [262]
0
0
Harderwijk
Query!
Country [263]
0
0
Netherlands
Query!
State/province [263]
0
0
Heerlen
Query!
Country [264]
0
0
Netherlands
Query!
State/province [264]
0
0
Hilversum
Query!
Country [265]
0
0
Netherlands
Query!
State/province [265]
0
0
Hoorn
Query!
Country [266]
0
0
Netherlands
Query!
State/province [266]
0
0
Nijmegen
Query!
Country [267]
0
0
Netherlands
Query!
State/province [267]
0
0
Rotterdam
Query!
Country [268]
0
0
Netherlands
Query!
State/province [268]
0
0
Sneek
Query!
Country [269]
0
0
Netherlands
Query!
State/province [269]
0
0
Tiel
Query!
Country [270]
0
0
Netherlands
Query!
State/province [270]
0
0
Tilburg
Query!
Country [271]
0
0
Netherlands
Query!
State/province [271]
0
0
Zwijndrecht
Query!
Country [272]
0
0
Norway
Query!
State/province [272]
0
0
Arendal
Query!
Country [273]
0
0
Norway
Query!
State/province [273]
0
0
Gjettum
Query!
Country [274]
0
0
Norway
Query!
State/province [274]
0
0
Kristiansand
Query!
Country [275]
0
0
Norway
Query!
State/province [275]
0
0
Oslo
Query!
Country [276]
0
0
Norway
Query!
State/province [276]
0
0
Skien
Query!
Country [277]
0
0
Norway
Query!
State/province [277]
0
0
Stavanger
Query!
Country [278]
0
0
Norway
Query!
State/province [278]
0
0
Ã…lesund
Query!
Country [279]
0
0
Poland
Query!
State/province [279]
0
0
Bialystok
Query!
Country [280]
0
0
Poland
Query!
State/province [280]
0
0
Gdansk
Query!
Country [281]
0
0
Poland
Query!
State/province [281]
0
0
Gdynia
Query!
Country [282]
0
0
Poland
Query!
State/province [282]
0
0
Katowice
Query!
Country [283]
0
0
Poland
Query!
State/province [283]
0
0
Krakow
Query!
Country [284]
0
0
Poland
Query!
State/province [284]
0
0
Lublin
Query!
Country [285]
0
0
Poland
Query!
State/province [285]
0
0
Stalowa Wola
Query!
Country [286]
0
0
Poland
Query!
State/province [286]
0
0
Tarnow
Query!
Country [287]
0
0
Poland
Query!
State/province [287]
0
0
Walbrzych
Query!
Country [288]
0
0
Poland
Query!
State/province [288]
0
0
Warszawa
Query!
Country [289]
0
0
Poland
Query!
State/province [289]
0
0
Wroclaw
Query!
Country [290]
0
0
Poland
Query!
State/province [290]
0
0
Zabrze
Query!
Country [291]
0
0
Poland
Query!
State/province [291]
0
0
Zielona Gora
Query!
Country [292]
0
0
Portugal
Query!
State/province [292]
0
0
Coimbra
Query!
Country [293]
0
0
Portugal
Query!
State/province [293]
0
0
Faro
Query!
Country [294]
0
0
Portugal
Query!
State/province [294]
0
0
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Russian Federation
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Funding & Sponsors
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Commercial sector/industry
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Name
Amgen
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00358215
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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. 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.
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Public notes
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Contacts
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MD
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Amgen
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No information has been provided regarding IPD availability
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No Supporting Document Provided
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Results not provided in
https://clinicaltrials.gov/study/NCT00358215
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