Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT00530361
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT00530361
Study Brief:
Protocol Section:
NCT00530361