NCT00047775

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2001

Typical duration for phase_4

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2002

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

June 24, 2005

Status Verified

October 1, 2004

First QC Date

October 18, 2002

Last Update Submit

June 23, 2005

Conditions

Congestive Heart Failure

Interventions

BiDilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Cooper Green Hospital

Birmingham, Alabama, 35233, United States

Location

Cardiology and Medicine Clinic

Little Rock, Arkansas, 72204, United States

Location

Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

Miami International Cardiology Consultants

Aventura, Florida, 33180, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Saint Vincents Hospital and Medical Center

New York, New York, 10011, United States

Location

Related Publications (2)

  • 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.

    PMID: 24970468DERIVED

  • 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.

    PMID: 21742102DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

isosorbide-hydralazine combination

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Anne L. Taylor, M.D.

    University of Minnesota

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 18, 2002

First Posted

October 21, 2002

Study Start

May 1, 2001

Study Completion

August 1, 2004

Last Updated

June 24, 2005

Record last verified: 2004-10

Locations

US(7)