NCT00288730

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 placebo in the treatment of patients with symptomatic, decompressed congestive heart failure (CHF).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 1996

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1996

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1997

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2006

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

First QC Date

February 3, 2006

Last Update Submit

June 9, 2011

Conditions

Heart Failure, CongestiveHeart Decompensation

Keywords

Heart FailureRenal DysfunctionCardiomyopathyHeart DecompensationDyspnea Paroxysmal

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic effects assessed by an increase in cardiac output without an increase in heart rate, measured at 1.5, 3, 4.5 and 6 hours.

Secondary Outcomes (1)

  • Hemodynamic improvements sustained throughout at least 24 hours of infusion: improvements in overall clinical status and specific signs and symptoms of CHF after 6 hours of treatment; reduction in plasma aldosterone levels.

Study Arms (1)

001

EXPERIMENTAL

nesiritide

Drug: nesiritide

Interventions

nesiritideDRUG
001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 10400005RESULT

MeSH Terms

Conditions

Heart FailureRenal InsufficiencyCardiomyopathiesDyspnea, Paroxysmal

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDyspneaRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Scios, Inc. Clinical Trial

    Scios, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 3, 2006

First Posted

February 8, 2006

Study Start

October 1, 1996

Study Completion

August 1, 1997

Last Updated

June 10, 2011

Record last verified: 2011-06