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African-American Heart Failure Trial

N

Nitromed

Status and phase

Completed
Phase 4

Conditions

Congestive Heart Failure

Treatments

Drug: BiDil

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Full description

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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