Heart Failure and Anemia

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Impact of Subcutaneous (SC) Darbepoetin Alfa Treatment on Exercise Tolerance in Subjects With Symptomatic Heart Failure (CHF) and Anemia.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00049985

Enrollment

300

Registered

2002-11-19

Start date

2002-07-31

Completion date

Unknown

Last updated

2009-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Heart Failure

Brief summary

The purpose of this study is to determine whether increasing hemoglobin concentration in patients with heart failure and anemia will improve the patients' functional status, including exercise tolerance and New York Heart Association (NYHA) classification.

Interventions

DRUGDarbepoetin Alfa

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

- At least 21 years of age - Symptomatic CHF for at least 3 months - Limited exercise tolerance on a treadmill - 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 - Unable to do cardiopulmonary exercise testing - 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

Design outcomes

Primary

Measure	Time frame
Exercise tolerance	—

Secondary

Measure	Time frame
NYHA classification; patient-reported outcomes	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026