Back to resultsAfrican-American Heart Failure Trial
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
BiDil
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure
Eligibility 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).
Sites / Locations
- Cooper Green Hospital
- Cardiology and Medicine Clinic
- Howard University Hospital
- Miami International Cardiology Consultants
- Boston Medical Center
- Minneapolis VA Medical Center
- Saint Vincents Hospital and Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00047775
Brief Title
African-American Heart Failure Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2004
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Nitromed
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
1100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
BiDil
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne L. Taylor, M.D.
Organizational Affiliation
University of Minnesota
Official's Role
Study Chair
Facility Information:
Facility Name
Cooper Green Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Cardiology and Medicine Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Miami International Cardiology Consultants
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Minneapolis VA Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Saint Vincents Hospital and Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24970468
Citation
Anand IS, Win S, Rector TS, Cohn JN, Taylor AL. Effect of fixed-dose combination of isosorbide dinitrate and hydralazine on all hospitalizations and on 30-day readmission rates in patients with heart failure: results from the African-American Heart Failure Trial. Circ Heart Fail. 2014 Sep;7(5):759-65. doi: 10.1161/CIRCHEARTFAILURE.114.001360. Epub 2014 Jun 26.
Results Reference
derived
PubMed Identifier
21742102
Citation
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. doi: 10.1016/j.ahj.2011.04.022.
Results Reference
derived
Learn more about this trial
African-American Heart Failure Trial
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