Congestive Heart Failure
Conditions
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.
Interventions
DRUGBiDil
Sponsors
Nitromed
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Countries
United States
Outcome results
None listed