Status:
COMPLETED
A Study of Two Doses of Intravenous NATRECOR hBNP (Nesiritide) in Patients With Worsening Congestive Heart Failure Who Have Difficulty Breathing at Rest
Lead Sponsor:
Scios, Inc.
Conditions:
Heart Failure, Congestive
Heart Decompensation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and efficacy of two doses of intravenous NATRECOR® hBNP (a recombinant form of the natural human peptide normally secreted by the heart) versus place...
Detailed Description
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 horm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 1997
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00288730
Start Date
October 1 1996
End Date
August 1 1997
Last Update
June 10 2011
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