African-American Heart Failure Trial - Full Text View

Sponsored by:	Nitromed
Information provided by:	Nitromed
ClinicalTrials.gov Identifier:	NCT00047775

Purpose

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

Condition	Intervention	Phase
Congestive Heart Failure	Drug: BiDil	Phase IV

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Nitromed:

Estimated Enrollment:

1100

Study Start Date:

May 2001

Estimated Study Completion Date:

August 2004

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.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047775

Locations

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

More Information

Study ID Numbers:

A-HeFT

First Received:

October 18, 2002

Last Updated:

June 23, 2005

ClinicalTrials.gov Identifier:

NCT00047775

Health Authority:

United States: Food and Drug Administration

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 06, 2009