Study Complete
Sponsor ID
20050222
RED-HF™ Trial – Reduction of Events with Darbepoetin alfa in Heart Failure Trial
Study Details
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.
Protocol Summary
Primary Outcome Measures
To determine the efficacy of darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening HF in subjects with symptomatic left ventricular systolic dysfunction and anemia.
Timeframe: Duration of study
Secondary Outcome Measures
To evaluate the effects of treatment with darbepoetin alfa on time to death from any cause
Timeframe: Duration of study
To evaluate the effects of treatment with darbepoetin alfa on time to cardiovascular death or first hospital admission for worsening HF, whichever occurs first
Timeframe: Duration of study
To evaluate the effects of treatment with darbepoetin alfa on change from baseline to month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Timeframe: Six months
To evaluate the effects of treatment with darbepoetin alfa on change from baseline to month 6 in KCCQ Symptom Frequency Score
Timeframe: Six months
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Troy, NY, United States, 12180
Status
Completed
Location
Research Site
Mobile, AL, United States, 36608
Status
Recruiting
Location
Research Site
Natick, MA, United States, 01760
Status
Completed
Location
Research Site
Huntsville, AL, United States, 35801
Status
Recruiting
Location
Research Site
Bridgeport, CT, United States, 06606
Status
Recruiting
Location
Research Site
Lincoln, NE, United States, 68506
Status
Recruiting
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