Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA
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ClinicalTrials.gov Identifier: NCT00653042 |
Recruitment Status :
Completed
First Posted : April 4, 2008
Last Update Posted : May 19, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Bypass Surgery Coronary Heart Disease Coronary Artery Bypass Grafting Cardiopulmonary Bypass Ischemic Heart Disease Congestive Heart Failure | Drug: Nesiritide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 305 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | A Pilot, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Nesiritide Infusion, Initiated Post-Induction of Anesthesia, in the Management of Coronary Artery Bypass Graft (CABG) Patients Requiring CardioPulmonary Bypass (CPB) |
Study Start Date : | March 2004 |
Actual Study Completion Date : | June 2005 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653042
Study Director: | Scios, Inc. Clinical Trial | Scios, Inc. |
ClinicalTrials.gov Identifier: | NCT00653042 |
Obsolete Identifiers: | NCT00090792 |
Other Study ID Numbers: |
CR003352 |
First Posted: | April 4, 2008 Key Record Dates |
Last Update Posted: | May 19, 2011 |
Last Verified: | March 2010 |
Myocardial Ischemia kidney failure CABG cardiopulmonary bypass (CPB) pump |
Coronary Artery Bypass Surgery heart surgery nesiritide Coronary Heart Disease |
Heart Failure Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Cardiovascular Diseases |
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