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: October 23, 2013
Last verified: October 2013
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrolled 13 June 2006; Last patient enrolled 4 May 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.

Participant Flow:   Overall Study
    Placebo     Darbepoetin Alfa  
STARTED     1142     1136  
Received Investigational Product     1140     1133  
COMPLETED     463 [1]   484 [1]
NOT COMPLETED     679     652  
Ineligibility determined                 4                 3  
Adverse Event                 83                 65  
Withdrawal by Subject                 111                 102  
Participant request                 65                 64  
Physician Decision                 47                 39  
Lost to Follow-up                 16                 22  
Death                 265                 281  
Protocol Violation                 64                 59  
Pregnancy                 1                 0  
Other                 21                 14  
Did not receive investigational product                 2                 3  
[1] Participants who completed investigational product



  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.
No text entered.

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  
Number of Participants  
[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  
Kansas City Cardiomyopathy Questionnaire: Overall Summary Score [2]
[units: units on a scale]
Mean ± Standard Deviation
  56.5  ± 22.5     55.8  ± 22.6     56.2  ± 22.5  
Study Specific Characteristic [Kansas City Cardiomyopathy Questionnaire: Symptom Frequency Scale [3]
[units: units on a scale]
Mean ± Standard Deviation
  63.3  ± 25.2     63.1  ± 25.6     63.2  ± 25.4  
[1] Usage of implantable cardioverter defibrillator / cardiac resynchronization therapy (ICD/CRT)
[2] 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.
[3] 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


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