Subcutaneous (SC) Darbepoetin Alfa in Subjects With Symptomatic Congestive Heart Failure (CHF) & Anemia

Amgen150 enrolled

Overview

The purpose of this study is to evaluate whether weight-based or fixed starting doses result in comparable hemoglobin increases and treatment effects in patients with heart failure and anemia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Congestive Heart Failure Anemia

Interventions

Darbepoetin AlfaDRUG

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: - Symptomatic CHF for at least 3 months - Reduced left ventricular ejection fraction - Stable heart failure medication - Hemoglobin concentration between 9.0 and 12.5 g/dL Exclusion Criteria: - Hypertension - Unstable angina pectoris or recent myocardial infarction - Likely to receive cardiac transplant - Major organ transplant (e.g., lung, liver, heart) or in renal replacement therapy (e.g., dialysis) - Recent or current treatment for malignancy - Systemic hematologic disease - Anemia due to acute or chronic bleeding - Recent Epogen® or darbepoetin alfa therapy - Recent blood transfusion

Outcomes

Primary Outcomes

Rate of rise of hemoglobin concentration

Secondary Outcomes

Change in left ventricular ejection fraction

Change in 6-minute walk distance

NYHA classification

Patient-reported outcomes

Data from ClinicalTrials.gov

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