African-American Heart Failure Trial - Tabular View

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African-American Heart Failure Trial

This study has been completed.

Study NCT00047775. Last updated on June 23, 2005. Information provided by Nitromed

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.