Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass (LEVO-CTS)

Protocol:
NCT02025621
Phase:
III

A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass

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).

Are you Eligible? (Inclusion Criteria)

  • LVEF ≤35%
  • 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 cardiopulmonary bypass pump

Specialty Area(s)

Cardiac

Trial Location

NewYork-Presbyterian/Columbia University Medical Center
Department of Surgery
New York, NY 10032
United States