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 Caliber of Blood Vessels

NCT ID: NCT00271557

Last Updated: 2011-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 305 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-01-31
• Study Completion Date: 1997-12-31

Brief 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.

Detailed Description

The data from these previous studies suggest that doses of NATRECOR® 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 support of copious salt outputs by the renal system not provided by currently available therapies. The purpose of this safety study is to evaluate NATRECOR® hBNP in subjects with symptomatic, decompensated congestive heart failure for whom inpatient intravenous therapy with medications that influence the tone and caliber of blood vessels (other than, or in addition to, IV diuretics) is deemed appropriate. This is a multi-center, randomized, open-label, safety study designed to compare two doses of NATRECOR® hBNP for the treatment of decompensated congestive heart failure. One treatment group receives NATRECOR® hBNP fixed-dose infusion IV bolus of 0.3 µg/kg followed by a 0.015 µg/kg/min infusion; group two receives IV bolus of 0.6 µg/kg followed by a 0.03 µg/kg/min infusion. The duration of NATRECOR® hBNP therapy is determined by the attending physician. The study hypothesis is that doses of NATRECOR® hBNP in the range of 0.015 to 0.03 µg/kg/min provide an optimal safety/efficacy profile for the treatment of decompensated CHF. One treatment group receives NATRECOR® hBNP fixed-dose infusion IV bolus of 0.3 µg/kg followed by a 0.015 µg/kg/min infusion; group two receives IV bolus of 0.6 µg/kg followed by a 0.03 µg/kg/min infusion. The duration of NATRECOR® hBNP therapy is determined by the attending physician.

Conditions

Heart Failure, Congestive; Heart Decompensation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

nesiritide

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scios, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Scios, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Scios, Inc.

References

Mills RM, LeJemtel TH, Horton DP, Liang C, Lang R, Silver MA, Lui C, Chatterjee K. Sustained hemodynamic effects of an infusion of nesiritide (human b-type natriuretic peptide) in heart failure: a randomized, double-blind, placebo-controlled clinical trial. Natrecor Study Group. J Am Coll Cardiol. 1999 Jul;34(1):155-62. doi: 10.1016/s0735-1097(99)00184-9.

Reference Type: RESULT

PMID: 10400005 (View on PubMed)

Other Identifiers

CR005203

Identifier Type: -

Identifier Source: org_study_id