Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by (Responsible Party):
Amgen Identifier:
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
Cardiovascular Disease
Ventricular Dysfunction
Congestive Heart Failure
Interventions: Drug: Darbepoetin alfa
Drug: Placebo

  Participant Flow

  Baseline Characteristics
  Hide Baseline Characteristics

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
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  
[units: years]
Mean (Standard Deviation)
  69.6  (11.3)     70.0  (11.6)     69.8  (11.4)  
[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  
[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 [2]
[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.

  Outcome Measures
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.

  More Information