African-American Heart Failure Trial - Full Text View

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 August 28, 2008

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