A Study to Develop Additional Safety and Clinical Experience With NATRECOR hBNP (Nesiritide) in the Treatment of Patients With Worsening Congestive Heart Failure Who Require Inpatient Intravenous Therapy With Medications That Influence the Tone and

• Status: Completed
• Trial end date: 1997-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this safety study is to evaluate NATRECOR® hBNP (a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure), in subjects with worsening congestive heart failure for whom inpatient intravenous therapy with medications that influence the tone and caliber of blood vessels is deemed appropriate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scios, Inc.
• Treatments: Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

• Patients with a previous history of chronic congestive heart failure (CHF)

• presenting with symptomatic, decompensated CHF for inpatient intravenous therapy with medications that influence the tone and caliber of blood vessels (other than, or in addition to, diuretics)

Exclusion Criteria:

• Patients with myocardial ischemia within the past 48 hours

• having significant valvular stenosis, obstructive cardiomyopathy, constrictive pericarditis or primary pulmonary hypertension

• being treated with intravenous (IV) therapy with medications that influence the tone and caliber of blood vessels for > 4 hours for this episode of CHF

• already being treated with IV therapy with medications that influence the tone and caliber of blood vessels that cannot be discontinued

• having cardiogenic shock, systolic blood pressure consistently < 90 mm Hg or other significant blood circulation instability.