Status:
COMPLETED
Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA
Lead Sponsor:
Scios, Inc.
Conditions:
Coronary Artery Bypass Surgery
Coronary Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
In coronary heart disease (CHD), the coronary arteries become clogged with calcium and fatty deposits. The deposits, called plaques, narrow the arteries that carry blood to the heart muscle and could ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT00653042
Start Date
March 1 2004
End Date
June 1 2005
Last Update
May 19 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.