NCT02025621

Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 882 (actual)
• Sponsor: Tenax Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study is being done to evaluate the efficacy of levosimendan compared with placebo in reducing the co-primary endpoints of 30-day composite of all-cause death or use of mechanical assist device (IABP, LVAD or ECMO) or the composite event rate of all-cause death, perioperative MI, need for dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on CPB.

Conditions

• Coronary Artery Bypass Grafting
• Mitral Valve Surgery
• Low Cardiac Output Syndrome

Interventions

Type	Name	Description
DRUG	Levosimendan
DRUG	Placebo	matching placebo

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2014-01-01
• Last updated: 2018-06-21
• Results posted: 2018-05-22

Locations

60 sites across 2 countries: United States, Canada