Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scios, Inc.
• Treatments: Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• Pulmonary disease (COPD, asthma or other condition) that required inpatient medical or surgical treatment within 60 days before surgery. Treatment exclusion criteria (obtained after anesthesia induction and before chest incision prior to the start of study drug) include: mean pulmonary artery pressure consistently < or equal to 15mmHg

• 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.