Heart Failure and Anemia

This study has been completed.

Sponsor:

Information provided by:

Amgen

ClinicalTrials.gov Identifier:

NCT00049985

First received: November 18, 2002

Last updated: August 6, 2009

Last verified: August 2009

History of Changes

Purpose

The purpose of this study is to determine whether increasing hemoglobin concentration in patients with heart failure and anemia will improve the patients' functional status, including exercise tolerance and New York Heart Association (NYHA) classification.

Condition	Intervention	Phase
Heart Failure Anemia	Drug: Darbepoetin Alfa	Phase 2

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 Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Impact of Subcutaneous (SC) Darbepoetin Alfa Treatment on Exercise Tolerance in Subjects With Symptomatic 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

Secondary Outcome Measures:

NYHA classification; patient-reported outcomes

Estimated Enrollment:	300
Study Start Date:	July 2002

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: - At least 21 years of age - Symptomatic CHF for at least 3 months - Limited exercise tolerance on a treadmill - Reduced left ventricular ejection fraction - Stable heart failure medication - Hemoglobin concentration between 9.0 and 12.5 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 in 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: NCT00049985

Sponsors and Collaborators

Amgen

Investigators

Study Director:

Amgen

More Information

Additional Information:

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

Publications:

Ghali JK, Anand IS, Abraham WT, Fonarow GC, Greenberg B, Krum H, Massie BM, Wasserman SM, Trotman ML, Sun Y, Knusel B, Armstrong P; Study of Anemia in Heart Failure Trial (STAMINA-HeFT) Group. Randomized double-blind trial of darbepoetin alfa in patients with symptomatic heart failure and anemia. Circulation. 2008 Jan 29;117(4):526-35. Epub 2008 Jan 14.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00049985 History of Changes
Other Study ID Numbers:	20010170
Study First Received:	November 18, 2002
Last Updated:	August 6, 2009
Health Authority:	United States: Food and Drug Administration

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 June 18, 2013

To Top