African-American Heart Failure Trial

June 23, 2005 updated by: Nitromed
A placebo-controlled trial of BiDil added to standard therapy in African-American patients with heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

1100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Cooper Green Hospital
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Cardiology and Medicine Clinic
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University Hospital
    • Florida
      • Aventura, Florida, United States, 33180
        • Miami International Cardiology Consultants
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Medical Center
    • New York
      • New York, New York, United States, 10011
        • Saint Vincents Hospital and Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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).

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: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

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

Sponsor

Nitromed

Investigators

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

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

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

May 1, 2001

Study Completion

August 1, 2004

Study Registration Dates

First Submitted

October 18, 2002

First Submitted That Met QC Criteria

October 18, 2002

First Posted (Estimate)

October 21, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

October 1, 2004

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-HeFT

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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