Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On… (NCT02025621) | Clinical Trial Compass
CompletedPhase 3
Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass
United States882 participantsStarted 2014-07
Plain-language summary
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on cardiopulmonary bypass (CPB).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented LVEF ≤35% measured by ventriculogram, echocardiogram (ECHO), nuclear scan, or MRI within 60 days before surgery.
* Scheduled or urgent 1) CABG surgery, 2)CABG with aortic valve surgery, 3) CABG with mitral valve surgery, or 4) mitral valve surgery with or without other valves
* Surgery will employ CPB pump
* Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
* Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent on venous return.
* Evidence of systemic bacterial, systemic fungal, or viral infection within 72 hours before surgery.
* Dialysis at randomization (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration).
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2.
* Weight ≥ 170 kg.
* Patients whose SBP cannot be managed to ensure SBP \> 90 mmHg at initiation of study drug.
* Heart rate ≥ 120 bpm, persistent for at least 10 minutes screening and unresponsive to treatment.
* Hemoglobin \< 80 g/L.
* Serum potassium \< 3.5 mmol/L and \> 5.5 mmol/L at baseline.
* A history of Torsades de Pointes.
* Mechanical assist device (IABP, LVAD, ECMO) in the patient at the start of surg…