Terminated/Withdrawn
Sponsor ID
20060172

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

Sponsor ID
20060172
Clinicaltrials.gov ID
NCT00534456
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 3
Product
darbepoetin alfa
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
12
Additional Study Details

Protocol Summary

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.

Timeframe: 12 months

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.

Timeframe: 12 months

Investigate the effect of treatment of anemia with darbepoetin alfa on novel biomarkers relevant to the pathophysiology and progression of heart failure

Timeframe: 12 months

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.