African-American Heart Failure Trial

NCT ID: NCT00047775

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2004-08-31

Brief Summary

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

Detailed Description

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

Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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BiDil

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nitromed

INDUSTRY

Sponsor Role lead

Principal Investigators

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Anne L. Taylor, M.D.

Role: STUDY_CHAIR

University of Minnesota

Locations

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Cooper Green Hospital

Birmingham, Alabama, United States

Site Status

Cardiology and Medicine Clinic

Little Rock, Arkansas, United States

Site Status

Howard University Hospital

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

Site Status

Miami International Cardiology Consultants

Aventura, Florida, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

Site Status

Saint Vincents Hospital and Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24970468 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21742102 (View on PubMed)

Other Identifiers

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A-HeFT

Identifier Type: -

Identifier Source: org_study_id