Study Stopped
Study terminated
An Exploratory Sub-study for the RED-HF™ (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial
Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Darbepoetin Alfa Treatment on Cardiac Function and Disease Specific Biomarkers in Subjects With Symptomatic Left Ventricular Systolic Dysfunction and Anemia: An Exploratory Sub-study for the RED-HF™ Trial
1 other identifier
interventional
12
0 countries
N/A
Brief Summary
The purpose of Study 20060172 was to measure echocardiographic parameters and biomarkers in a subgroup of study subjects enrolled in Study 20050222 (the RED-HF Trial). This substudy 20060172 was terminated early due to feasibility constraints. All subjects enrolled in 20060172 were also enrolled in Study 20050222, which is ongoing. Study data will be analyzed when Study 20050222 ends, since unblinding before then would adversely affect Study 20050222.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2007
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 20, 2007
CompletedFirst Posted
Study publicly available on registry
September 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedApril 8, 2011
April 1, 2011
9 months
September 20, 2007
April 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine whether treatment of anemia with darbepoetin alfa, in patients with heart failure and anemia, results in changes in cardiac structure and function.
12 months
Secondary Outcomes (2)
Explore correlations among measures of cardiac systolic and diastolic function, surrogate markers of cardiac injury and function, and clinical outcomes in heart failure subjects treated with darbepoetin alfa or placebo.
12 months
Investigate the effect of treatment of anemia with darbepoetin alfa on novel biomarkers relevant to the pathophysiology and progression of heart failure
12 months
Study Arms (2)
Active
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Placebo group to receive volume and dose frequency changes resembling titration dosing in the treatment group.
Starting dose: 0.75 mcg/kg subcutaneously Q2W. Subsequent doses: Darbepoetin alfa group to receive darbepoetin alfa titrated to achieve Hb target of 13.0 g/dL, not to exceed 14.5 g/dL.
Eligibility Criteria
You may qualify if:
- Signed informed consent for Study 20060172
- Randomized into Study 20050222
You may not qualify if:
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, render the subject unsuitable for accurate echocardiography, may confound the study results, or may interfere significantly with the subject's participation in Study 20060172 or in Study 20050222.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 20, 2007
First Posted
September 24, 2007
Study Start
January 1, 2007
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
April 8, 2011
Record last verified: 2011-04