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)
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).
Coronary Artery Bypass Surgery
Coronary Heart Disease
Coronary Artery Bypass Grafting
Ischemic Heart Disease
Heart Failure, Congestive
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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 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.
- 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.
|Estimated Study Completion Date:||September 2009|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530361
|Study Director:||Scios, Inc. Clinical Trial||Scios, Inc.|