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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
  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 4

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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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 - Clinical and Translational Science Institute
  More Information

No publications provided by Nitromed

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00047775     History of Changes
Other Study ID Numbers: A-HeFT
Study First Received: October 18, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013