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

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ClinicalTrials.gov Identifier: NCT00117234
Recruitment Status : Completed
First Posted : July 6, 2005
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Congestive Heart Failure Anemia Drug: darbepoetin alfa

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Study to Assess the Impact of Subcutaneous (SC) Darbepoetin Alfa Treatment on Exercise Tolerance and Left Ventricular Structure in Subjects With Symptomatic Congestive Heart Failure (CHF) and Anemia
Study Start Date : September 2002
Estimated Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Exercise tolerance, measured as peak VO(subscript)2

Secondary Outcome Measures :
  1. Exercise duration; *NYHA classification; *Patient-reported outcomes

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117234


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00117234     History of Changes
Other Study ID Numbers: 20020126
First Posted: July 6, 2005    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by Amgen:
chronic heart failure
congestive heart failure
low hemoglobin
anemia
CHF
Symptomatic Congestive Heart Failure (CHF)

Additional relevant MeSH terms:
Heart Failure
Anemia
Heart Diseases
Cardiovascular Diseases
Hematologic Diseases
Darbepoetin alfa
Hematinics