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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00358215
First received: July 27, 2006
Last updated: July 14, 2014
Last verified: July 2014
Results First Received: October 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Heart Failure
Anemia
Cardiovascular Disease
Ventricular Dysfunction
Congestive Heart Failure
Interventions: Drug: Darbepoetin alfa
Drug: Placebo

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
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.
Total Total of all reporting groups

Baseline Measures
   Placebo   Darbepoetin Alfa   Total 
Overall Participants Analyzed 
[Units: Participants]
 1142   1136   2278 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.6  (11.3)   70.0  (11.6)   69.8  (11.4) 
Gender 
[Units: Participants]
     
Female   486   458   944 
Male   656   678   1334 
Race/Ethnicity, Customized 
[Units: Participants]
     
White or Caucasian   768   781   1549 
Black or African American   113   89   202 
Hispanic or Latino   84   98   182 
Asian   162   162   324 
Japanese   0   1   1 
American Indian or Alaska Native   2   2   4 
Native Hawaiian or Other Pacific Islander   1   0   1 
Other   12   3   15 
Region 
[Units: Participants]
     
North America   323   321   644 
Latin America and Asia   286   285   571 
Western Europe, Israel, South Africa, Australia   306   303   609 
Eastern Europe and Russia   227   227   454 
Device Usage [1] 
[Units: Participants]
     
CRT with or without ICD   143   143   286 
ICD without CRT   124   122   246 
None   875   871   1746 
[1] Usage of implantable cardioverter defibrillator / cardiac resynchronization therapy (ICD/CRT)
Kansas City Cardiomyopathy Questionnaire: Overall Summary Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 56.5  (22.5)   55.8  (22.6)   56.2  (22.5) 
[1] The KCCQ is a patient-reported measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Burden and Stability, Physical and Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, quality of life, fewer symptoms). Number of participants with available data = 1106 and 1104 for each treatment group respectively, total = 2210.
Study Specific Characteristic [Kansas City Cardiomyopathy Questionnaire: Symptom Frequency Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 63.3  (25.2)   63.1  (25.6)   63.2  (25.4) 
[1] The KCCQ is a patient-reported measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Burden and Stability, Physical and Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, quality of life, fewer symptoms). Number of participants with available data = 1106 and 1104 for each treatment group respectively, total = 2210.


  Outcome Measures
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1.  Primary:   Time to All Cause Death or First Hospitalization for Worsening Heart Failure   [ Time Frame: From randomization to the end of study; maximum time on study was 73 months ]

2.  Secondary:   Time to Death From Any Cause   [ Time Frame: From randomization to the end of study; maximum time on study was 73 months ]

3.  Secondary:   Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure   [ Time Frame: From randomization to the end of study; maximum time on study was 73 months ]

4.  Secondary:   Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score   [ Time Frame: Baseline and Month 6 ]

5.  Secondary:   Change From Baseline to Month 6 in KCCQ Symptom Frequency Score   [ Time Frame: Baseline and Month 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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