Trial record 1 of 2 for:
red-hf
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:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00534456
First received: September 20, 2007
Last updated: April 7, 2011
Last verified: April 2011
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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 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 May 23, 2013