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A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH):
Alberto Zangrillo1, Gabriele Alvaro2, Antonio Pisano3
1Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Anesthesia and Intensive Care, Policlinico Universitario "Magna Grecia," Catanzaro, Italy.
Insights
This study investigates levosimendan for cardiac surgery patients with low cardiac output syndrome. Levosimendan may reduce 30-day mortality in these high-risk patients.
Area of Science:
- Cardiology
- Anesthesiology
- Critical Care Medicine
Background:
- Patients undergoing cardiac surgery face risks of perioperative low cardiac output syndrome (LCOS) due to myocardial dysfunction.
- Levosimendan, a calcium sensitizer, offers inotropic, vasodilatory, and anti-inflammatory effects, showing promise for improving outcomes in LCOS.
Purpose of the Study:
- To determine if levosimendan improves survival in cardiac surgery patients experiencing LCOS.
- To evaluate the efficacy of levosimendan in managing postoperative myocardial dysfunction.
Main Methods:
- A double-blind, placebo-controlled, multicenter randomized trial involving 1,000 cardiac surgery patients.
- Patients with postoperative myocardial dysfunction received either levosimendan (0.05-0.2 μg/kg/min) or placebo infusion for 24-48 hours.
Main Results:
- The primary endpoint is 30-day mortality.
- Secondary endpoints include 1-year mortality, mechanical ventilation duration, acute kidney injury, and length of stay.
Conclusions:
- This trial aims to provide crucial data on levosimendan's role in improving survival for LCOS patients post-cardiac surgery.
- Results may significantly influence the clinical management strategies for low cardiac output in this population.
Objective:
Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes.
Design:
Double-blind, placebo-controlled, multicenter randomized trial.
Setting:
Tertiary care hospitals.
Interventions:
Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 μg/[kg min]) or placebo for 24-48 hours.
Measurements And Main Results:
The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction.
Conclusions:
This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery.
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