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

Amgen

Status and phase: Terminated; Phase 3

Conditions: Anemia; Ventricular Dysfunction; Heart Failure; Congestive Heart Failure; Cardiovascular Disease

Treatments: Drug: Placebo; Drug: Darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00534456

20060172

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Active

Experimental group

Treatment:

Drug: Darbepoetin alfa

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo