About the study

LEVOTAKO is a multicentre, randomised, double-blind clinical trial evaluating the efficacy and safety of levosimendan in patients with Takotsubo syndrome (TTS) and reduced left ventricular ejection fraction.

Participants are randomly assigned in a 1:1 ratio to receive either levosimendan or placebo, in addition to standard heart failure therapy administered according to current ESC guidelines.

What is Takotsubo syndrome?

Takotsubo syndrome (TTS) is a rare heart condition that clinically resembles an acute myocardial infarction. It accounts for approximately 1–3% of patients referred for coronary angiography with suspected heart attack.

The condition most commonly affects postmenopausal women and is characterised by transient impairment of cardiac contractile function despite the absence of significant coronary artery stenosis.

Although previously considered relatively benign, TTS is now recognised as a potentially life-threatening condition, particularly during the acute phase.

Why is a new treatment needed?

There are currently no randomised clinical trials that clearly define an effective treatment strategy for patients with Takotsubo syndrome.

Management is largely based on clinical experience and expert consensus, highlighting the need for well-designed clinical trials.

Why levosimendan?

Levosimendan is an inotropic and vasodilatory agent that increases cardiac contractility without impairing myocardial relaxation.

Preliminary data suggest that its use in patients with TTS may shorten hospital stay and accelerate recovery of cardiac function.

However, these findings require confirmation in a randomised clinical trial such as LEVOTAKO.

Study design

The study is designed as a randomised, double-blind, placebo-controlled clinical trial, allowing an objective evaluation of both efficacy and safety.

Patients receive either levosimendan or placebo in addition to standard heart failure treatment.

Study objectives

The primary objective is to determine whether administration of levosimendan during the acute phase of TTS accelerates recovery of left ventricular ejection fraction (LVEF) and reduces the risk of major cardiovascular events.

The study will also evaluate mortality, hospitalisations, treatment duration and cardiac biomarkers.

Study population

The study enrols patients aged 60 years and older diagnosed with Takotsubo syndrome and reduced left ventricular ejection fraction (LVEF ≤ 40%).

Diagnosis is established according to the internationally recognised InterTAK diagnostic criteria.

Detailed eligibility criteria should be confirmed directly with the study centre.

Why this study matters

If efficacy is confirmed, levosimendan may become the first well-documented treatment option for patients with Takotsubo syndrome, improving prognosis and quality of life in this patient population.

Organisational information

The project is funded by the Medical Research Agency (MRA), project number: 2022/ABM/01/00007.

Project duration: 01 July 2022 – 30 June 2027.

Total project value: PLN 11,272,763.50.