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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00534456
• Other study ID #: 20060172
• Status: Terminated
• Phase: Phase 3
• First received: September 20, 2007
• Last updated: April 7, 2011
• Start date: January 2007
• Est. completion date: October 2007

Study information

• Verified date: April 2011
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lithuania: State Medicines Control Agency of LithuaniaUnited States: Food and Drug AdministrationCanada: Health CanadaCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Cardiovascular Disease
• Cardiovascular Diseases
• Congestive Heart Failure
• Heart Failure
• Ventricular Dysfunction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	Investigate the effect of treatment of anemia with darbepoetin alfa on novel biomarkers relevant to the pathophysiology and progression of heart failure		12 months	Yes

External Links

•   AmgenTrials clinical trials website