A Study of Two Doses of Intravenous NATRECOR hBNP (Nesiritide) in Patients With Worsening Congestive Heart Failure Who Have Difficulty Breathing at Rest

Launched by SCIOS, INC. · Feb 3, 2006

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ClinConnect Summary

Human studies reported by SJ Holmes et al, 1993, AM Richards et al, 1993 and M. Yoshimara et al, 1991 show that administration of externally produced hBNP produces vasodilation; antagonism of the hormone system that helps regulate long term blood pressure and blood volume in the body; and an increase in urine output containing large amounts of salt. These studies suggest hBNP may be a potent agent for the treatment of acute congestive heart failure (CHF) with a unique combination of desirable effects on the flow of blood throughout the body; the hormones secreted by the nervous system; and ...

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Eligibility criteria

• Inclusion Criteria:
• • History of chronic congestive heart failure (CHF)
• • symptomatic, decompensated CHF for which intravenous therapy is deemed appropriate for the hospitalized patient
• • documentation of pulmonary capillary wedge pressure (PCWP) \>= 18 mm Hg, Cl \<= 2.7 mL/min/m² and systolic blood pressure \>= 90 mm Hg with consistent baseline hemodynamic measurements.
• Exclusion Criteria:
• • Had a myocardial infarction within the previous 48 hours or unstable angina
• • stroke within the previous 3 months or other evidence of significantly compromised central nervous system perfusion
• • has significant valvular stenosis hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, biopsy-proven active myocarditis, or complex congenital heart disease
• • receiving ongoing treatment with an intravenous vasostrictive agent for this episode of decompressed CHF that could not be discontinued for an appropriate washout period to permit the reassessment of baseline hemodynamic and clinical status prior to initiating drug study
• • clinical status so unstable that the subject can not tolerate placement of a Swan-Ganz catheter.