A Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Levosimendan Therapy in low ejection fraction Takotsubo Syndrome (LevoTako Trial)

Description of the study: Takotsubo syndrome (TTS), also known as apical ballooning syndrome, Takotsubo cardiomyopathy, broken heart syndrome, and stress-induced cardiomyopathy, is a rare condition and accounts for 1–3% of all patients referred to hemodynamic laboratories with a primary diagnosis of acute coronary syndrome (ACS).

The primary objective of the study is to assess whether the use of levosimendan in TTS improves LVEF in TTE 72 ± 3 hours after the end of the levosimendan infusion (primary primary endpoint). linical benefit will be defined as a reduction in the incidence of adverse major cardiovascular events such as all-cause death, TTS recurrence or worsening heart failure leading to unscheduled hospitalization, stroke or TIA (major secondary endpoint) over the 12-month follow-up period.

Medical University of Gdansk

Protocol number:

EudraCT number:

Project Manager/Main Investigator:
prof. dr n. med. Miłosz Jaguszewski

Duration of the study:
2022 - 2027