Early Use of Levosimendan Compared to Placebo with Standard Inotropic Treatment in Adults with Cardiogenic Shock to Improve Survival and Morbidity

What this Trial Is About

Researchers are evaluating the early use of levosimendan compared to a placebo added to standard inotropic treatment in adults with cardiogenic shock, a condition with a high mortality rate of about 40%. The study aims to determine whether levosimendan can improve heart function and speed recovery by allowing earlier discontinuation of dobutamine, which is commonly used but lacks strong evidence for its effectiveness in this setting. This is a phase 3 randomized clinical trial with triple masking to ensure unbiased results. Participants are randomly assigned to one of two groups an experimental group receiving levosimendan infusion and a control group receiving a placebo infusion, both alongside conventional inotropic therapy. The infusion is administered continuously over 24 hours, starting at 0.1 mcgkgmin and potentially increased to 0.2 mcgkgmin after 2 to 4 hours if needed. The study evaluates the combination of levosimendan or placebo with current standard care, following strict dosing protocols. During the study, participants will be closely monitored for mortality, use of life support devices, dialysis, and other cardiovascular events at multiple time points up to one year. Researchers will measure outcomes including death rates, need for extracorporeal life support, dialysis, heart transplant, and hospital stay duration. Safety will be assessed alongside heart function indicators and biomarkers. The total follow-up extends to 12 months after randomization to capture both short- and long-term effects.

Effect of Early Use of Levosimendan Versus Placebo on Top of a Conventional Strategy of Inotrope Use on a Combined Morbidity-mortality Endpoint in Patients With Cardiogenic Shock