Heart Failure and Anemia

August 6, 2009 updated by: Amgen

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Exercise tolerance

Secondary Outcome Measures

Outcome Measure
NYHA classification; patient-reported outcomes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Registration Dates

First Submitted

November 18, 2002

First Submitted That Met QC Criteria

November 18, 2002

First Posted (Estimate)

November 19, 2002

Study Record Updates

Last Update Posted (Estimate)

August 7, 2009

Last Update Submitted That Met QC Criteria

August 6, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20010170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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