Impact of Darbepoetin Alfa on Exercise Tolerance and Left Ventricular Structure in Subjects With Symptomatic Congestive Heart Failure (CHF) and Anemia

Amgen

Status: Completed

Conditions: Anemia; Congestive Heart Failure

Treatments: Drug: darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00117234

20020126

Details and patient eligibility

About

The purpose of this study was to evaluate the effect of treatment with darbepoetin alfa on peak oxygen consumption (peak VO2) in subjects with symptomatic CHF and anemia.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - Symptomatic CHF for at least 3 months - Reduced left ventricular ejection fraction - Stable heart failure medication - Peak VO2 less than or equal to 16 ml/kg/min - Hemoglobin concentration between 9.0 and 12.0 g/dL Exclusion Criteria: - Hypertension - Unstable angina pectoris or recent myocardial infarction - Likely to receive cardiac transplant - Unable to do cardiopulmonary exercise testing - Major organ transplant (e.g., lung, liver, heart) or renal replacement therapy (e.g., dialysis) - Recent or current treatment for malignancy - Systemic hematologic disease - Anemia due to acute or chronic bleeding - Recent Epogen® or darbepoetin alfa therapy - Recent blood transfusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind