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African-American Heart Failure Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00047775
Recruitment Status : Completed
First Posted : October 21, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Nitromed

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

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: BiDil Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : May 2001
Study Completion Date : August 2004

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047775


Locations
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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
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Study Chair: Anne L. Taylor, M.D. University of Minnesota
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00047775    
Other Study ID Numbers: A-HeFT
First Posted: October 21, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: October 2004
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases