Coronary Artery Bypass SurgeryPhase 2NCT00653042
Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA
A Phase 2 study testing Nesiritide in people with Coronary Artery Bypass Surgery and Coronary Heart Disease, run by Scios, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Surgery, Coronary Heart Disease, Coronary Artery Bypass Grafting
- What is being tested?
- Nesiritide
- How many people
- 305 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Jun 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
About this study
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)
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).
Read the 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.
- Conditions
- Coronary Artery Bypass Surgery, Coronary Heart Disease, Coronary Artery Bypass Grafting, Cardiopulmonary Bypass, Ischemic Heart Disease, Congestive Heart Failure
- Being tested
- Nesiritide
- Keywords
- Myocardial Ischemia, kidney failure, CABG, cardiopulmonary bypass (CPB) pump, Coronary Artery Bypass Surgery, heart surgery, nesiritide, Coronary Heart Disease
- Medical subject headings
- Coronary Disease, Myocardial Ischemia, Heart Failure, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NesiritideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startMar 2004
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scios, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scios, Inc. Clinical Trial, Study director, Scios, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653042
- Sponsor's protocol ID
- CR003352
- Status last verified
- Mar 2010
- First submitted
- 1 Apr 2008
- Last updated
- 19 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00653042
- Acronym / sponsor ID
- CR003352
- Conditions
- Coronary Artery Bypass Surgery, Coronary Heart Disease, Coronary Artery Bypass Grafting, Cardiopulmonary Bypass, Ischemic Heart Disease, Congestive Heart Failure
- Keywords
- Myocardial Ischemia, kidney failure, CABG, cardiopulmonary bypass (CPB) pump, Coronary Artery Bypass Surgery, heart surgery, nesiritide, Coronary Heart Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Scios, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Jun 2005 (actual)
- First posted
- 4 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nesiritide | Drug | – |
Primary outcome
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
1 secondary outcome
Time to extubation, Time to discharge from ICU/CCU and hospital, Time on CPB, Adverse Events, and Change from baseline in hemodynamic parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- Clinical study to evaluate nesiritide in patients undergoing Coronary Artery Bypass Graft (CABG) surgery A014 / NAPALink provided by the sponsor.
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Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scios, Inc. Clinical Trial study director
Scios, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nesiritide in people with Coronary Artery Bypass Surgery and Coronary Heart Disease, run by Scios, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.