Not recruitingRare disease

Study of Levosimendan and Glucose Monohydrate for Patients with Low Ejection Fraction Takotsubo Syndrome

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Takotsubo syndrome, which is a temporary heart condition often triggered by stress. The study is investigating the effects of a treatment called Levosimendan, which is a medication that helps the heart pump more effectively. The trial will compare the effects of Levosimendan to a placebo to see if it can help patients recover heart function more quickly and reduce the risk of future heart-related problems.

Participants in the study will receive the treatment through an intravenous infusion, which means the medication is delivered directly into the bloodstream. The main goal is to see if Levosimendan can improve the heart's ability to pump blood during the hospital stay and reduce the chances of serious heart events, such as heart failure or stroke, over the next year.

The study will follow participants for a period of time to monitor their heart health and any potential side effects. By comparing the outcomes of those receiving Levosimendan with those receiving a placebo, researchers hope to determine the effectiveness of this treatment for people with Takotsubo syndrome and a low heart pumping ability, known as low ejection fraction.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, current hospitalization due to Takotsubo syndrome, and left ventricular ejection fraction (LVEF) of 40% or less, or a decrease in LVEF by 10% or more compared to previous values.
An echocardiogram is performed within 24 hours of admission to assess LVEF. Additionally, NTproBNP concentration is measured to ensure it is 500 pg/mL or higher.
Step 2
Randomization and treatment
Participants are randomly assigned to receive either the study medication, levosimendan, or a placebo. This process is double-blind, meaning neither the participant nor the medical staff knows which treatment is being administered.
The medication is administered intravenously as a solution for infusion. The specific dosage and frequency are determined by the study protocol.
Step 3
Monitoring and follow-up
During the hospital stay, participants are monitored for recovery of LVEF. This is the primary endpoint of the study.
Participants are also observed for any major adverse cardiovascular events, such as rehospitalization due to Takotsubo syndrome recurrence, heart failure, stroke, or transient ischemic attack (TIA).
Step 4
Long-term follow-up
After discharge, participants are followed for 12 months to track all-cause mortality and any major adverse cardiovascular events.
The study aims to determine if levosimendan accelerates in-hospital LVEF recovery and reduces the incidence of these events compared to placebo.

Who can join the trial?

4 criteria

Must be older than 60 years.
Currently in the hospital because of **Takotsubo syndrome**. This is a temporary heart condition often brought on by stress.
Heart's pumping ability, known as **left ventricular ejection fraction (LVEF)**, must be 40% or less, as checked by an ultrasound of the heart within 24 hours of arriving at the hospital. Alternatively, if the LVEF has decreased by 10% or more compared to the last recorded value before this hospital stay.
Blood test showing **NTproBNP** levels of 500 pg/mL or higher. NTproBNP is a substance that the heart releases when it is under stress.

Who cannot join the trial?

5 criteria

Patients who do not have Takotsubo syndrome cannot participate. This is a temporary heart condition often brought on by stress.
Patients with a left ventricular ejection fraction (LVEF) greater than 40% at admission cannot participate. LVEF is a measurement of how well the heart is pumping blood.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients are eligible, so gender is not an exclusion factor.
Patients who are part of a vulnerable population may be excluded. This refers to groups who might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Gornoslaskie Centrum Mwdyczne
Katowice, Poland
Responsive
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Warsaw, Poland
Responsive
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland

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Investigated drugs

Levosimendan is a medication being studied for its potential benefits in patients with Takotsubo Syndrome, a condition that affects the heart's ability to pump blood effectively. The trial is investigating whether this medication can help improve heart function and reduce the risk of serious heart-related events over a year. Levosimendan is not typically used for this condition, so the study is exploring its effects when used in this new way.

What is already known about the treatment

Levosimendan – Levosimendan is administered intravenously and is currently being studied in clinical trials for its potential benefits in treating Takotsubo syndrome, particularly in patients with low ejection fraction. It is not yet widely established in medical practice for this condition, as research is ongoing to determine its effectiveness and safety. The main therapeutic indication being explored is its ability to improve heart function and reduce adverse cardiovascular events in Takotsubo syndrome. At the molecular level, levosimendan works by enhancing the sensitivity of the heart muscle to calcium, which improves cardiac contractility without significantly increasing oxygen demand. It is classified pharmacologically as a calcium sensitizer and inodilator.

Investigated diseases

Takotsubo syndrome – This condition is a temporary heart problem that often mimics a heart attack. It is characterized by sudden weakening of the heart's left ventricle, the main pumping chamber. The syndrome is often triggered by severe emotional or physical stress. Symptoms can include chest pain, shortness of breath, and irregular heartbeats. Unlike a heart attack, there is no blockage in the coronary arteries. The heart usually recovers its normal function over time.