Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

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

The LevoTako study is a major clinical trial investigating a medicine called Levosimendan for patients experiencing Takotsubo Syndrome. This condition, sometimes called 'broken heart syndrome,' temporarily weakens the heart. The trial aims to find out if Levosimendan can help the heart's pumping ability (ejection fraction) recover more quickly while a patient is in hospital. Researchers want to compare this medicine to a dummy treatment (placebo) to see if it makes a real difference. They are also checking how patients fare over a year, looking at important events like returning to hospital or other heart-related issues. This study involves many hospitals and is for adults aged 18 and over, both men and women.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Medical University Of Gdansk

Enrolment target

190

Start

16 Dec 2024

Takotsubo syndrome

What is this study about?

This study, called the LevoTako Trial, is looking into a medicine named Levosimendan for a heart condition called Takotsubo Syndrome. Takotsubo Syndrome is a temporary condition where the heart muscle suddenly becomes weak, often after severe emotional stress, like grief or shock. It's sometimes known as 'broken heart syndrome,' but it can affect men and women of any age.

In this trial, doctors want to see if Levosimendan can help the heart's main pumping chamber (the left ventricle) recover its strength faster while patients are still in the hospital. The medicine will be compared to a 'placebo,' which looks exactly like the medicine but contains no active drug. This is done so researchers can accurately tell if any improvements are due to the medicine itself or other factors. Both the patients and their doctors won't know who is getting the real medicine and who is getting the placebo, which helps make the study as fair and accurate as possible.

Beyond checking the heart's recovery in the hospital, the study will also follow patients for a year to see if the medicine affects their overall health. They will look at whether people need to come back to the hospital due to the syndrome recurring, or if they experience other heart-related problems. This kind of research is really important because it helps doctors understand the best ways to treat Takotsubo Syndrome and improve outcomes for people who experience it.

Key takeaways

The study tests a medicine (Levosimendan) for Takotsubo Syndrome.
It aims to see if the heart recovers faster while in hospital.
Patients will receive either the medicine or a dummy treatment (placebo).
You'll be followed for up to 12 months after starting treatment.
Participation is for adults aged 18 and over, both men and women.
You can stop participating at any time you wish.

Who may be eligible?

To be considered for this study, you would need to be 18 years old or older. The study is open to both men and women.

The main thing is that you would have recently been diagnosed with Takotsubo Syndrome.

There might be other specific health requirements or conditions that would mean you couldn't take part. These are usually discussed in detail with your doctor who can check if the trial is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently been diagnosed with Takotsubo Syndrome?
Are you able to stay in hospital for the initial treatment phase?
Are you able to attend follow-up appointments for up to 12 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication (Levosimendan or a placebo) while you are in the hospital. This medicine is given through a drip into your arm.

During your hospital stay, doctors would regularly check your heart's pumping ability and overall health. After you leave the hospital, you would continue to be followed by the study team for up to 12 months. This follow-up would involve checking in with you to see how you are feeling and if you have had any further health problems related to your heart condition, such as needing to return to hospital. The total time you would be involved in the study from start to finish would be about a year.

Potential risks and benefits

Taking part in a study like this could potentially help your heart recover faster from Takotsubo Syndrome, though this is not guaranteed as it's what the study aims to find out. There's also the chance that the medicine might not help, or you might receive the placebo. All medicines have potential side effects, and the study team would carefully monitor you for any. You would be fully informed about known risks of the study medicine before you decide to participate. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland

Common questions

What is Takotsubo Syndrome?

It's a temporary heart condition, sometimes called 'broken heart syndrome,' where stress makes your heart muscle suddenly weaken.

What is Levosimendan?

It's a medicine being tested to see if it helps the heart recover faster in people with Takotsubo Syndrome.

What does 'placebo' mean?

A placebo is a dummy treatment that looks like the real medicine but contains no active drug. It helps ensure the study results are fair.

How long will I be in the study?

You would be followed for up to 12 months in total, starting from when you begin the treatment in the hospital.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without affecting your medical care.