Status:
COMPLETED
RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
Lead Sponsor:
Amgen
Conditions:
Heart Failure
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Detailed Description
Several epidemiological studies have demonstrated an association between HF and anemia and correlation of increased risk for mortality and hospitalization with low hemoglobin in patients with HF. Earl...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- 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)
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2012
Estimated Enrollment :
2278 Patients enrolled
Trial Details
Trial ID
NCT00358215
Start Date
June 1 2006
End Date
October 11 2012
Last Update
November 8 2022
Active Locations (754)
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1
Research Site
Birmingham, Alabama, United States, 35211
2
Research Site
Birmingham, Alabama, United States, 35294
3
Research Site
Huntsville, Alabama, United States, 35801
4
Research Site
Mobile, Alabama, United States, 36608