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

This study has been completed.

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00117234

Purpose

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	Intervention
Congestive Heart Failure Anemia	Drug: darbepoetin alfa

MedlinePlus related topics: Anemia Exercise and Physical Fitness Heart Failure

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Amgen:

Primary Outcome Measures:

Exercise tolerance, measured as peak VO(subscript)2

Secondary Outcome Measures:

Exercise duration; *NYHA classification; *Patient-reported outcomes

Study Start Date:	September 2002
Estimated Study Completion Date:	July 2004

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117234

Sponsors and Collaborators

Amgen

Investigators

Study Director:

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Ponikowski P, Anker SD, Szachniewicz J, Okonko D, Ledwidge M, Zymlinski R, Ryan E, Wasserman SM, Baker N, Rosser D, Rosen SD, Poole-Wilson PA, Banasiak W, Coats AJ, McDonald K. Effect of darbepoetin alfa on exercise tolerance in anemic patients with symptomatic chronic heart failure: a randomized, double-blind, placebo-controlled trial. J Am Coll Cardiol. 2007 Feb 20;49(7):753-62. Epub 2007 Feb 5.

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20020126
Study First Received:	June 30, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00117234
Health Authority:	Ireland: Irish Medicines Board

Keywords provided by Amgen:

chronic heart failure
congestive heart failure
low hemoglobin

anemia
CHF
Symptomatic Congestive Heart Failure (CHF)

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Hematologic Diseases
Darbepoetin alfa
Anemia

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009