NCT00049985

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2 heart-failure

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2002

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

First QC Date

November 18, 2002

Last Update Submit

August 6, 2009

Conditions

Heart FailureAnemia

Outcome Measures

Primary Outcomes (1)

  • Exercise tolerance

Secondary Outcomes (1)

  • NYHA classification; patient-reported outcomes

Interventions

Darbepoetin AlfaDRUG

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ghali JK, Anand IS, Abraham WT, Fonarow GC, Greenberg B, Krum H, Massie BM, Wasserman SM, Trotman ML, Sun Y, Knusel B, Armstrong P; Study of Anemia in Heart Failure Trial (STAMINA-HeFT) Group. Randomized double-blind trial of darbepoetin alfa in patients with symptomatic heart failure and anemia. Circulation. 2008 Jan 29;117(4):526-35. doi: 10.1161/CIRCULATIONAHA.107.698514. Epub 2008 Jan 14.

    PMID: 18195176RESULT

Related Links

MeSH Terms

Conditions

Heart FailureAnemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 18, 2002

First Posted

November 19, 2002

Study Start

July 1, 2002

Last Updated

August 7, 2009

Record last verified: 2009-08