Coronary Artery Bypass SurgeryPhase 3NCT00530361
An Efficacy and Safety Study for Nesiritide in Heart Failure Patients With Reduced Kidney Function Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass (CPB Pump or Heart Lung Machine)
A Phase 3 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 whether nesiritide compared to placebo when given with standard of care therapies, helps preserve kidney function in heart failure (HF) patients undergoing heart bypass graft surgery that requires the use of a cardiopulmonary bypass machine (CPB pump or heart-lung machine). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Artery Bypass Surgery, Coronary Heart Disease, Coronary Artery Bypass Grafting
- What is being tested?
- Nesiritide
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Sep 2009
- Phase
- Phase 3
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with history of congestive heart failure
- Documentation of left ventricular ejection fraction (LVEF)<= 40% within 90 days before surgery
- Pre-existing renal insufficiency with a glomerular filtration rate of <= 60 mL/min/1.73 m2 measured within 24 hours before surgery
- Scheduled to undergo coronary artery bypass graft (CABG) surgery with or without mitral valve replacement or repair on Cardiopulmonary Bypass machine.
Who cannot join
- History of cardiac disease or conditions in which cardiac output is dependent on venous return or Pulmonary disease (COPD), asthma, or other conditions that have required inpatient medical or surgical treatment within 60 days before surgery
- Documented systemic bacterial/fungal/viral infection within 72 hours before surgery
- Known acute renal failure or ongoing chronic dialysis at baseline
- Any of the following: mean pulmonary artery pressure <= 15 mmHg, central venous pressure < 6 mmHg, or systolic blood pressure < 90 mmHg before surgery
- Planned aortic valve repair or replacement
- Pregnant, suspected to be pregnant, or breast feeding
Show all 9Show fewer
- Received an experimental drug or used an experimental medical device within 30 days before the planned start of study drug
- Known allergic reaction or sensitively to nesiritide or excipients
- Received commercial nesiritide within 48 hours before the planned start of study drug or was previously randomized in the NAPA-CS study.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study of Nesiritide Administered After Induction of Anesthesia in Heart Failure Patients With Renal Insufficiency Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass (NAPA-CS)
The purpose of this study is to assess whether nesiritide compared to placebo when given with standard of care therapies, helps preserve kidney function in heart failure (HF) 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 or 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 . The study drug (nesiritide) or placebo dose being studied is 0.010 mcg/kg/min via continuous IV infusion. The study hypothesis is that compared to placebo, nesiritide will reduce kidney ischemia, preserve glomerular filtration rate (GFR),which measures the rate at which the kidneys filter blood, and the need for dialysis or occurrence of death in HF patients who have undergone heart bypass surgery requiring the use of a cardiopulmonary bypass machine. Safety will be assessed through the collection of adverse events, clinical laboratory tests, vital signs, physical examinations and electrocardiograms at various time points throughout the study. 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 48 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, Heart Failure, Congestive
- 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.
The composite of a 25% decrease in postoperative glomerular filtration rate, occurrence of postoperative dialysis, and all-cause mortality through Day 30; The composite of occurrence of postoperative dialysis and all-cause mortality through Day 90.
Secondary outcomes (1)
The occurrence of new-onset postoperative atrial fibrillation through 96 hours after randomization. The composite of re-intubation for respiratory failure and all-cause mortality through 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study completionSep 2009 (estimated)
Why it stopped: Study was withdrawn prior to patient dosing based on a business decision.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 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
- NCT00530361
- Sponsor's protocol ID
- CR014266
- Status last verified
- Jul 2011
- First submitted
- 13 Sep 2007
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study of Nesiritide Administered After Induction of Anesthesia in Heart Failure Patients With Renal Insufficiency Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass (NAPA-CS)
- ClinicalTrials.gov ID
- NCT00530361
- Acronym / sponsor ID
- CR014266
- Conditions
- Coronary Artery Bypass Surgery, Coronary Heart Disease, Coronary Artery Bypass Grafting, Cardiopulmonary Bypass, Ischemic Heart Disease, Heart Failure, Congestive
- Keywords
- Myocardial Ischemia, Kidney failure, CABG, Cardiopulmonary bypass (CPB) pump, Coronary Artery Bypass Surgery, Heart surgery, Nesiritide, Coronary Heart Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn prior to patient dosing based on a business decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Scios, Inc.Industry (pharma, biotech, devices)
- Study completion
- Sep 2009 (estimated)
- First posted
- 17 Sep 2007 (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 whether nesiritide compared to placebo when given with standard of care therapies, helps preserve kidney function in heart failure (HF) 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 or 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 . The study drug (nesiritide) or placebo dose being studied is 0.010 mcg/kg/min via continuous IV infusion. The study hypothesis is that compared to placebo, nesiritide will reduce kidney ischemia, preserve glomerular filtration rate (GFR),which measures the rate at which the kidneys filter blood, and the need for dialysis or occurrence of death in HF patients who have undergone heart bypass surgery requiring the use of a cardiopulmonary bypass machine. Safety will be assessed through the collection of adverse events, clinical laboratory tests, vital signs, physical examinations and electrocardiograms at various time points throughout the study. 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 48 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with history of congestive heart failure
- Documentation of left ventricular ejection fraction (LVEF)<= 40% within 90 days before surgery
- Pre-existing renal insufficiency with a glomerular filtration rate of <= 60 mL/min/1.73 m2 measured within 24 hours before surgery
- Scheduled to undergo coronary artery bypass graft (CABG) surgery with or without mitral valve replacement or repair on Cardiopulmonary Bypass machine.
Key exclusion criteria (9 listed)
- History of cardiac disease or conditions in which cardiac output is dependent on venous return or Pulmonary disease (COPD), asthma, or other conditions that have required inpatient medical or surgical treatment within 60 days before surgery
- Documented systemic bacterial/fungal/viral infection within 72 hours before surgery
- Known acute renal failure or ongoing chronic dialysis at baseline
- Any of the following: mean pulmonary artery pressure <= 15 mmHg, central venous pressure < 6 mmHg, or systolic blood pressure < 90 mmHg before surgery
- Planned aortic valve repair or replacement
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
The composite of a 25% decrease in postoperative glomerular filtration rate, occurrence of postoperative dialysis, and all-cause mortality through Day 30; The composite of occurrence of postoperative dialysis and all-cause mortality through Day 90.
1 secondary outcome
The occurrence of new-onset postoperative atrial fibrillation through 96 hours after randomization. The composite of re-intubation for respiratory failure and all-cause mortality through 30 days.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
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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 3 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 9 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: withdrawn, as of the sponsor's last update on 20 Sep 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
The composite of a 25% decrease in postoperative glomerular filtration rate, occurrence of postoperative dialysis, and all-cause mortality through Day 30; The composite of occurrence of postoperative dialysis and all-cause mortality through Day 90.. 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 20 Sep 2016.