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Study Complete
Sponsor ID
20020126

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

Sponsor ID
20020126
Clinicaltrials.gov ID
NCT00117234
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
N/A
Product
darbepoetin alfa
Type
Interventional
Masking
N/A
Enrollment
N/A
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Locations

No locations found.
Study Info
Age
21+ years
Condition
  • Heart Failure
  • Anemia
    • Sex
    All
    Trial Dates
    Sep 2002 - N/A
    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