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African-American Heart Failure Trial

Sponsor
Nitromed (Industry)
Overall Status
Completed
CT.gov ID
NCT00047775
Collaborator
(none)
1,100
Enrollment
7
Locations
39
Duration (Months)
157.1
Patients Per Site
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A placebo-controlled trial of BiDil added to standard therapy in African-American patients with heart failure.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The overall objective is confirmation of BiDil's Safety and Efficacy in African-American (AFA) Patients with Moderate to Severe Symptomatic Heart Failure.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double
Primary Purpose:
Treatment
Study Start Date :
May 1, 2001
Study Completion Date :
Aug 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    • African American male or female 18 years or older.

    • NYHA Class 3 & 4.

    • Have either a resting LVEF less than or equal to 35% (by any method) or a resting LVIDD greater than 2.9 cm/m2 BSA (or greater than 6.5 cm) with LVEF less than 45% (by echocardiogram).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cooper Green Hospital Birmingham Alabama United States 35233
    2 Cardiology and Medicine Clinic Little Rock Arkansas United States 72204
    3 Howard University Hospital Washington District of Columbia United States 20060
    4 Miami International Cardiology Consultants Aventura Florida United States 33180
    5 Boston Medical Center Boston Massachusetts United States 02118
    6 Minneapolis VA Medical Center Minneapolis Minnesota United States 55417
    7 Saint Vincents Hospital and Medical Center New York New York United States 10011

    Sponsors and Collaborators

    • Nitromed

    Investigators

    • Study Chair: Anne L. Taylor, M.D., University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00047775
    Other Study ID Numbers:
    • A-HeFT
    First Posted:
    Oct 21, 2002
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Oct 1, 2004
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jun 24, 2005