Back to resultsHeart Failure and Anemia
Primary Purpose
Heart Failure, Anemia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Darbepoetin Alfa
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Exercise tolerance
Secondary Outcome Measures
NYHA classification; patient-reported outcomes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00049985
Brief Title
Heart Failure and Anemia
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Darbepoetin Alfa
Primary Outcome Measure Information:
Title
Exercise tolerance
Secondary Outcome Measure Information:
Title
NYHA classification; patient-reported outcomes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18195176
Citation
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. doi: 10.1161/CIRCULATIONAHA.107.698514. Epub 2008 Jan 14.
Results Reference
result
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Heart Failure and Anemia
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