NCT00653042

Brief Summary

The purpose of this study is to assess the effects of nesiritide compared to placebo when given with standard of care therapies, on kidney function, heart function and the need of other treatments in heart failure patients undergoing heart bypass graft surgery that requires the use of a cardiopulmonary bypass machine (CPB pump or heart-lung machine).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
305

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_2

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

March 1, 2004

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2008

Completed
Last Updated

May 19, 2011

Status Verified

March 1, 2010

First QC Date

April 1, 2008

Last Update Submit

May 18, 2011

Conditions

Coronary Artery Bypass SurgeryCoronary Heart DiseaseCoronary Artery Bypass GraftingCardiopulmonary BypassIschemic Heart DiseaseCongestive Heart Failure

Keywords

Myocardial Ischemiakidney failureCABGcardiopulmonary bypass (CPB) pumpCoronary Artery Bypass Surgeryheart surgerynesiritideCoronary Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline serum creatinine, total inotrope/vasopressor/vasodialator use during first 24 hours, average change from baseline of mean PAP for 24 hours from study start or after removal of catheter and 24-hour urine output after ICU/CCU admission

Secondary Outcomes (1)

  • Time to extubation, Time to discharge from ICU/CCU and hospital, Time on CPB, Adverse Events, and Change from baseline in hemodynamic parameters

Interventions

NesiritideDRUG

Eligibility Criteria

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

You may qualify if:

  • NYHA class II-IV CHF
  • Presenting for CABG with or without mitral valve repair or replacement procedure
  • Planned utilization of CPB
  • Documentation of left ventricular ejection fraction (LVEF) less than or equal to 40% measured by nuclear scan, echocardiogram (ECHO), or ventriculogram, within 90 days prior to surgery.

You may not qualify if:

  • Planned aortic valve replacement or repair
  • Ongoing or chronic dialysis (either hemodialysis or continuous ambulatory peritoneal dialysis)
  • Restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent on venous return
  • Documented or suspected low cardiac filling pressures
  • Any known congenital heart disease
  • Known allergic reaction or sensitivity to nesiritide or excipients
  • Females of childbearing potential with a positive serum pregnancy test, and nursing mothers
  • Treated with investigational drug or device within last 30 days
  • documented fever (\>101 degrees F) within 72 hours of surgery
  • WBC \> 15,000/mm3 within 72 hours of surgery
  • Documented bacterial/fungal/viral infection requiring administration of IV antibiotics within 7 days before surgery
  • central venous pressure consistently \< 6 mmHg
  • and systolic blood pressure consistently \< 90 mmHg. Use of open-label nesiritide within 48 hours of study drug administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Coronary DiseaseMyocardial IschemiaHeart FailureRenal Insufficiency

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

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 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 4, 2008

Study Start

March 1, 2004

Study Completion

June 1, 2005

Last Updated

May 19, 2011

Record last verified: 2010-03