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

Completed · Phase 3 · Has a placebo group

Conditions studied: Heart Failure, Anemia, Cardiovascular Disease, Ventricular Dysfunction, Congestive Heart Failure

In brief

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.

Key facts

Study ID

NCT00358215

Run by

Amgen

People needed

2278

Starts

2006-06-01

Expected to finish

2012-10-11

Last updated by the study team

2022-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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)

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Huntsville, Alabama, United States
• Research Site — Mobile, Alabama, United States
• Research Site — Gilbert, Arizona, United States
• Research Site — Mesa, Arizona, United States
• Research Site — Scottsdale, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Anaheim, California, United States
• Research Site — Buena Park, California, United States
• Research Site — Corona, California, United States
• Research Site — Culver City, California, United States
• Research Site — Downey, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Lancaster, California, United States
• Research Site — Larkspur, California, United States
• Research Site — Loma Linda, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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