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

Condition	Treatment or Intervention	Phase
Congestive Heart Failure	Drug: BiDil	Phase IV

The overall objective is confirmation of BiDil’s Safety and Efficacy in African-American (AFA) Patients with Moderate to Severe Symptomatic Heart Failure.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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).

Alabama
      Cooper Green Hospital, Birmingham,  Alabama,  35233,  United States
Arkansas
      Cardiology and Medicine Clinic, Little Rock,  Arkansas,  72204,  United States
District of Columbia
      Howard University Hospital, Washington,  District of Columbia,  20060,  United States
Florida
      Miami International Cardiology Consultants, Aventura,  Florida,  33180,  United States
Massachusetts
      Boston Medical Center, Boston,  Massachusetts,  02118,  United States
Minnesota
      Minneapolis VA Medical Center, Minneapolis,  Minnesota,  55417,  United States
New York
      Saint Vincents Hospital and Medical Center, New York,  New York,  10011,  United States

Study chairs or principal investigators

Anne L. Taylor, M.D.,  Study Chair,  University of Minnesota   

Study ID Numbers:  A-HeFT
Record last reviewed:  October 2004
Record first received:  October 18, 2002
ClinicalTrials.gov Identifier:  NCT00047775
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-29