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)

NCT00530361 | Withdrawn Phase 3

• 1 other identifier: CR014266
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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).

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

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Nesiritide DRUG

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scios, Inc.: lead

MeSH Terms

Conditions

Coronary Disease; Myocardial Ischemia; Heart Failure; Renal Insufficiency

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Scios, Inc. Clinical Trial

  Scios, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Completion: September 1, 2009
• Last Updated: September 20, 2016

Record last verified: 2011-07