Study Complete
Sponsor ID
20050222

RED-HF™ Trial – Reduction of Events with Darbepoetin alfa in Heart Failure Trial

Sponsor ID
20050222
Clinicaltrials.gov ID
NCT00358215
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 3
Product
darbepoetin alfa
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
2278
Additional Study Details

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
Status
Contact Us
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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