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

• Status: Completed
• Trial end date: 2012-10-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa

Criteria

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%

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)