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

This study has been terminated.
(Study terminated)
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00534456
First received: September 20, 2007
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Anemia
Cardiovascular Disease
Congestive Heart Failure
Heart Failure
Ventricular Dysfunction
Drug: Placebo
Drug: Darbepoetin alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: January 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534456

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00534456     History of Changes
Other Study ID Numbers: 20060172
Study First Received: September 20, 2007
Last Updated: April 7, 2011
Health Authority: Lithuania: State Medicines Control Agency of Lithuania
United States: Food and Drug Administration
Canada: Health Canada
Czech Republic: State Institute for Drug Control

Keywords provided by Amgen:
exploratory study
anemia
pharmacogenetics testing
biomarkers
echocardiography

Additional relevant MeSH terms:
Anemia
Cardiovascular Diseases
Heart Failure
Ventricular Dysfunction
Hematologic Diseases
Heart Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014