An Exploratory Sub-study for the RED-HF™ (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00534456
Recruitment Status : Terminated (Study terminated)
First Posted : September 24, 2007
Last Update Posted : April 8, 2011
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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.

Condition or disease Intervention/treatment Phase
Anemia Cardiovascular Disease Congestive Heart Failure Heart Failure Ventricular Dysfunction Drug: Placebo Drug: Darbepoetin alfa Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active Drug: Darbepoetin alfa
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.

Placebo Comparator: Placebo Drug: Placebo
Placebo group to receive volume and dose frequency changes resembling titration dosing in the treatment group.

Primary Outcome Measures :
  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. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]
  2. Investigate the effect of treatment of anemia with darbepoetin alfa on novel biomarkers relevant to the pathophysiology and progression of heart failure [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent for Study 20060172
  • Randomized into Study 20050222

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00534456

Sponsors and Collaborators
Study Director: MD Amgen

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00534456     History of Changes
Other Study ID Numbers: 20060172
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: April 8, 2011
Last Verified: April 2011

Keywords provided by Amgen:
exploratory study
pharmacogenetics testing

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Ventricular Dysfunction
Heart Diseases
Hematologic Diseases
Darbepoetin alfa