African-American Heart Failure Trial
Information source: Nitromed
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congestive Heart Failure
Intervention: BiDil (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Nitromed Official(s) and/or principal investigator(s):
Anne L. Taylor, M.D., Study Chair, Affiliation: University of Minnesota
Summary
A placebo-controlled trial of BiDil added to standard therapy in African-American patients
with heart failure.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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).
Locations and Contacts
Cooper Green Hospital, Birmingham, Alabama 35233, United States
Cardiology and Medicine Clinic, Little Rock, Arkansas 72204, United States
Howard University Hospital, Washington, District of Columbia 20060, United States
Miami International Cardiology Consultants, Aventura, Florida 33180, United States
Boston Medical Center, Boston, Massachusetts 02118, United States
Minneapolis VA Medical Center, Minneapolis, Minnesota 55417, United States
Saint Vincents Hospital and Medical Center, New York, New York 10011, United States
Additional Information
Starting date: May 2001
Ending date: August 2004
Last updated: June 23, 2005
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