African-American Heart Failure Trial - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

African-American Heart Failure Trial

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Congestive Heart Failure

Intervention ^†

Drug: BiDil

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

1100

Start Date ^†

May 2001

Completion Date

August 2004

Eligibility 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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00047775

Organization ID

A-HeFT

Secondary IDs ^††

Study Sponsor ^†

Nitromed

Collaborators ^††

Investigators ^†

Study Chair:

Anne L. Taylor, M.D.

University of Minnesota

Information Provided By

Nitromed

Verification Date

October 2004

First Received Date ^†

October 18, 2002

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.