Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Levosimendan · 3 trials · 8 indications
The all-cause death at 30 days or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) through Day 5
Composite of all-cause death (at 30 days), or perioperative nonfatal MI \[CK-MB \>10xULN or \>100 ng/mL, CK-MB \>5xULN or 50 ng/mL with new Q wave (\>0.04 seconds wide in two contiguous leads) or new left bundle branch block)\] (through Day 5), or need for renal dialysis (through Day 30), or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) (through Day 5)
Number of Adverse Events per Patient Population
Change from baseline Pulmonary Capillary Wedge Pressure (PCWP) with bicycle exercise at Week 6
| Arm | Type | Description |
|---|---|---|
| Levosimendan | EXPERIMENTAL | levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours |
| Placebo | PLACEBO_COMPARATOR | placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours |
| Levosimendan Open-Label | OTHER | Initial: A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion. Ongoing patients are transitioned to daily oral levosimendan (1mg capsules TID) |
| Levosimendan 2.5mg/mL Injectable Solution | EXPERIMENTAL | 0.075 - 0.1µg/kg/min for 24 hrs (weekly) |
| Matching Placebo | PLACEBO_COMPARATOR | 0.075 - 0.1µg/kg/min for 24 hrs (weekly) |
| Name | Type | Description |
|---|---|---|
| Levosimendan | DRUG | - |
| Placebo | DRUG | matching placebo |
| Matching Placebo | DRUG | A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion |
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 ot...