African-American Heart Failure Trial - Tabular View

Tracking Information

First Received Date ^ICMJE

October 18, 2002

Last Updated Date

June 23, 2005

Start Date ^ICMJE

May 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00047775 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

African-American Heart Failure Trial

Official Title ^ICMJE

Brief Summary

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

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Congestive Heart Failure

Intervention ^ICMJE

Drug: BiDil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1100

Completion Date

August 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00047775

Responsible Party

Study ID Numbers ^ICMJE

A-HeFT

Study Sponsor ^ICMJE

Nitromed

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Anne L. Taylor, M.D.

University of Minnesota

Information Provided By

Nitromed

Verification Date

October 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP