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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Anemia Exercise and Physical Fitness Heart Failure

Drug Information available for: Darbepoetin Alfa

U.S. FDA Resources

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:

MD

Amgen

More Information

Additional Information:

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

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

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00117234 History of Changes
Other Study ID Numbers:	20020126
Study First Received:	June 30, 2005
Last Updated:	December 2, 2010
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)

Additional relevant MeSH terms:

Anemia
Heart Failure
Hematologic Diseases
Heart Diseases
Cardiovascular Diseases

Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013