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

NCT00271557 | Completed Phase 3

• 1 other identifier: CR005203
• Study Type: interventional
• Target: 305
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure, Congestive; Heart Decompensation

Keywords

Heart Failure; Renal Dysfunction; Cardiomyopathy; Heart Decompensation; Dyspnea Paroxysmal.

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Adverse events, vital signs

Interventions

nesiritide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scios, Inc.: lead

Related Publications (1)

• 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.

  PMID: 10400005 RESULT

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency; Cardiomyopathies; Dyspnea, Paroxysmal

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Dyspnea; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Scios, Inc. Clinical Trial

  Scios, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 30, 2005
• First Posted: January 2, 2006
• Study Start: January 1, 1997
• Study Completion: December 1, 1997
• Last Updated: March 4, 2011

Record last verified: 2011-03