- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00653042
Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA
May 18, 2011 updated by: Scios, Inc.
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)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 cause ischemic heart disease (too little blood and oxygen reaching the heart muscle).
Coronary Artery Bypass Graft (CABG) surgery is a treatment option for ischemic heart disease.
CABG surgery is surgery to create new routes for blood to flow around narrowed and blocked arteries so that the heart muscle will receive needed oxygen and nutrients.
Acute kidney injury is a serious risk of CABG surgery while on CPB pump (heart-lung machine), which could result from ischemia during and following surgery.
This study is a double-blind (neither the patient nor the doctor knows whether the patient is assigned to receive study drug or placebo), randomized (assigned to treatment by chance), placebo-controlled (study drug results compared to placebo results) study to determine the effectiveness of nesiritide compared to placebo when given to HF patients undergoing CABG surgery requiring the use of a CPB pump .
Patients will be enrolled into the study until 250 patients have received study drug or placebo.
Patients will be randomized to one of two treatment groups in a 1:1 ratio (nesiritide plus standard care: placebo plus standard care) within each site.
Study medication administration will be initiated after measurement of qualifying baseline hemodynamics and prior to chest incision.
Nesiritide or placebo will be administered as a continuous IV infusion at a rate of 0.01 mcg/kg/min for a minimum of 24 hours and a maximum of 96 hours.
Patients will be followed through 30 days from start of study drug.
All patients may receive additional standard care medications including inotropes, pressors, vasopressin, antiarrhythmics, diuretics, nitrates, and nitric oxide as needed.
Patient safety will be monitored throughout the study through physical exams, vital signs (heart rate, blood pressure, respiratory rate, and temperature), blood tests, and side effects.
A follow-up communication 180 days after the start of study drug was implemented to collect mortality data.
The patients assigned to the nesiritide group will receive a continuous I.V. infusion at 0.010 mcg/kg/min of nesiritide for at least 24 hours and could be extended to up to 96 hours.
The patients assigned to the placebo group will receive matching placebo.
Study Type
Interventional
Enrollment (Actual)
305
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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 Outcome Measures
Outcome Measure |
---|
Time to extubation, Time to discharge from ICU/CCU and hospital, Time on CPB, Adverse Events, and Change from baseline in hemodynamic parameters
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
April 1, 2008
First Submitted That Met QC Criteria
April 1, 2008
First Posted (Estimate)
April 4, 2008
Study Record Updates
Last Update Posted (Estimate)
May 19, 2011
Last Update Submitted That Met QC Criteria
May 18, 2011
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR003352
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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