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. - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 30, 2005

Last Updated Date

May 8, 2009

Start Date ^†

December 1996

Current Primary Outcome Measures ^†

Changes in symptoms and signs of CHF after 6 hours and after 24 hours of treatment with NATRECORÂ® hBNP.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00271557 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Adverse events, vital signs

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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.

Official Title ^†

A Randomized, Open-Label, Active-Controlled, Multicenter Phase III Safety Study of Two Doses of NATRECOR® hBNP (Nesiritide) Administered as a Continuous Infusion in the Treatment of Decompensated CHF.

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Heart Failure, Congestive
Heart Decompensation

Intervention ^†

Drug: nesiritide

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

305

Completion Date

December 1997

Primary Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00271557

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Scios, Inc.

Collaborators ^††

Investigators ^†

Study Director:

Scios R&D, Inc. Clinical Trial

Scios, Inc.

Information Provided By

Scios, Inc.

Verification Date

October 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.