Efficacy and Safety of Darbepoetin alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects with Symptomatic Left Ventricular Systolic Dysfunction and Anemia (Red HF Study)
Study Description
To determine the efficacy of darbepoetin alfa compared with 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.
Contact Information
Status:
Name, Phone, Email:
Kirk Volkman, NP
Jerri Housley, Research Coordinator
801-585-5122
Kirk.volkman@hsc.utah.edu
Jerri.housley@hsc.utah.edu
Principle Investigator:
Edward Michael Gilbert, M.D.
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Participant Eligibility
Inclusion Criteria:- 18 years of age or greater at the time of randomization
- Heart failure for = 3 months, and of NYHA class II, III or IV at the time of randomization.
- Left ventricular ejection fraction =35%.
- Hemoglobin concentration must be = 9.0 g/dL and = 12.0 g/dL.
- Poorly controlled hypertension
- Serum creatinine > 3.5 mg/dL
- Implantable cardiac defibrillator (ICD) within 30 days prior to randomization
- Hypertrophic obstructive cardiomyopathy, active myocarditis, or constrictive pericarditis
- Major surgery, including thoracic or cardiac surgery, within 3 months prior to randomization.
- Anemia that is due to acute or chronic bleeding.
