Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritede in Subjects with Decompensated Heart Failure (ASCEND-HF)
The primary objective is to evaluate whether treatment with nesiritide improves patient outcomes (as measured by reduction in the composite of heart failure re-hospitalizations and all-cause Mortality through 30 days after randomization or heart failure symptoms (as measured by subject self-assessed Likert dyspnea scale at 6 and 24 hours after study drug initiation) compared with placebo when each is administered in addition to other standard therapies in subjects with acute decompensated heart failure.
200063
7000
18 years or older who are hospitalized for the management of acute decompensated heart failure, or who are diagnosed within 48 hours of hospitalization.
In addition to treatments usually used by doctors to treat your heart failure, by taking part in this study, you will be given nesiritide or placebo as a single (bolus) dose followed by continuous intravenous (IV-into a vein) infusion of nesiritide or placebo for a minimum of 24 hours (1 day) up to a maximum of 168 hours (7 days). Under certain circumstances your doctor may decide to start the infusion without giving you a bolus of study drug. The amount of time that you get study drug will be up to the study doctor.
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