African-American Heart Failure Trial

This study has been completed.

Sponsor:

Information provided by:

Nitromed

ClinicalTrials.gov Identifier:

NCT00047775

First received: October 18, 2002

Last updated: June 23, 2005

Last verified: October 2004

History of Changes

Tracking Information

First Received Date ^ICMJE

October 18, 2002

Last Updated Date

June 23, 2005

Start Date ^ICMJE

May 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

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

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

African-American Heart Failure Trial

Official Title ^ICMJE

Not Provided

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Congestive Heart Failure

Intervention ^ICMJE

Drug: BiDil

Study Arm (s)

Not Provided

Publications *

Mitchell JE, Tam SW, Trivedi K, Taylor AL, O'Neal W, Cohn JN, Worcel M. Atrial fibrillation and mortality in African American patients with heart failure: results from the African American Heart Failure Trial (A-HeFT). Am Heart J. 2011 Jul;162(1):154-9.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1100

Completion Date

August 2004

Primary Completion Date

Not Provided

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 Number ^ICMJE

NCT00047775

Other Study ID Numbers ^ICMJE

A-HeFT

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Nitromed

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Anne L. Taylor, M.D.

University of Minnesota - Clinical and Translational Science Institute

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

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