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)

• Status: Withdrawn
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scios, Inc.
• Treatments: Natriuretic Peptide, Brain

Criteria

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.