In this randomized, double-blind, placebo-controlled, parallel-group, multi-center outcomes trial, patients with acutely decompensated heart failure will be randomized to receive placebo or Natrecor for a minimum of 24 hours up to a maximum of seven days, in addition to standard care.
The primary objective of the trial is to assess whether treatment with Natrecor in addition to standard care, compared with placebo plus standard care, improves patient outcomes, as measured by reduction in the composite of heart failure rehospitalization and all-cause mortality through 30 days; or improves heart failure symptoms, as measured by a patient self-assessed dyspnea, or shortness of breath, scale at six and 24 hours after Natrecor initiation.
Additional clinical endpoints include measuring improvement in patient self-assessed overall well-being at 6 or 24 hours after Natrecor initiation; increase in the number of days alive and outside of the hospital at 30 days; and reduction of 30-day composite cardiovascular rehospitalization and cardiovascular mortality.