Coronary Heart Disease Clinical Trial
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)
Verified date | July 2011 |
Source | Scios, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Scios, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
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