Status:

COMPLETED

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

Lead Sponsor:

Amgen

Conditions:

Congestive Heart Failure

Anemia

Eligibility:

All Genders

21+ years

Phase:

NA

Brief Summary

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2002

Trial Type :

INTERVENTIONAL

End Date :

July 1 2004

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00117234

Start Date

September 1 2002

End Date

July 1 2004

Last Update

December 3 2010

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