Study on the Effects of Adenosine, Dipyridamole, and Apixaban in Patients with Takotsubo Syndrome

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What is this study about?

This clinical trial is focused on studying a condition known as , often referred to as “broken heart syndrome.” This condition can cause temporary heart muscle weakness, leading to symptoms similar to a heart attack. The study aims to explore the effects of different treatments on patients with this syndrome. One part of the study will investigate whether a combination of and can improve patient outcomes compared to the usual care. is a substance that can help regulate heart rhythm, while is a medication that helps prevent blood clots by keeping blood vessels open.

Another part of the study will examine if , a medication that helps prevent blood clots, can reduce the risk of clot-related events such as strokes or heart attacks in patients with . Participants in this study will be randomly assigned to receive either the study medications or a placebo, which is a substance with no active ingredients. The study will monitor participants over a period of up to 30 days to assess the effects of the treatments on heart function and the occurrence of any heart-related events.

The goal of this research is to determine if these treatments can provide better outcomes for patients with by improving heart function and reducing the risk of complications. Participants will undergo regular check-ups and assessments to track their progress and ensure their safety throughout the study. The findings from this trial could help improve the management and treatment of this condition in the future.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This confirms your understanding and agreement to participate in the clinical trial.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are 18 years or older and have a clinical diagnosis of Takotsubo Syndrome with an ejection fraction (EF) of less than 50% at baseline.

3 randomization 1

You will be randomly assigned to receive either the standard care or a combination of adenosine and dipyridamole. Adenosine is administered through infusion, while dipyridamole is taken orally as a prolonged-release capsule.

4 randomization 2

In this phase, you may be randomly assigned to receive apixaban or no antithrombotic treatment. Apixaban is taken orally as a film-coated tablet.

5 medication administration

If assigned to receive adenosine and dipyridamole, adenosine will be given as an infusion, and dipyridamole will be taken orally. If assigned to receive apixaban, it will be taken orally as a tablet. The specific dosage and frequency will be provided by the study team.

6 monitoring and follow-up

Your health will be monitored throughout the study. This includes regular assessments of your heart function, such as measuring the ejection fraction at 48-96 hours and checking for any thromboembolic events or cardiac complications up until day 30.

7 end of study

The study will conclude with a final assessment of your health and any outcomes related to the treatment. Long-term follow-up may occur at 6 months and annually for up to 10 years to monitor for any lasting effects or complications.

Who Can Join the Study?

Age must be 18 years or older.
Must have a clinical diagnosis of Takotsubo Syndrome, which includes having an ejection fraction (EF) of less than 50% at the start. Ejection fraction is a measurement of how well the heart is pumping blood.
Must provide written informed consent, which means agreeing to participate in the study after understanding all the details.

Who Cannot Join the Study?

Patients who have a history of Takotsubo syndrome cannot participate. Takotsubo syndrome is a temporary heart condition often brought on by stress.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have any other medical condition that the study doctors think would make it unsafe for them to participate cannot join the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Uppsala University Hospital	Uppsala	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
St. Olavs Hospital HF	Trondheim	Norway
Region Jaemtland Haerjedalen	Ostersund	Sweden
NU Hospital Group-Vaestra Goetalandsregionen	Trollhattan	Sweden
Karolinska University Hospital	Solna	Sweden
Region Joenkoepings Laen	Jönköping	Sweden
Rigshospitalet	Copenhagen	Denmark
Danderyds Sjukhus AB	Danderyd	Sweden
Region Oerebro Laen	Orebro	Sweden
Region Vaesterbotten	Umea	Sweden
Region Oestergoetland	Linkoping	Sweden
Region Skane Helsingborg Hospital	Helsingborg	Sweden
Skaraborg Hospital-Vaestra Goetalandsregionen	Skovde	Sweden
Region Dalarna	Falun	Sweden
Amzdco Uzosuyrbmo Hpwrhozt	Aarhus	Denmark
Sxmbxbiopzy Uyvjkyyjbu Hhdxentgmmztbbo Ghnwoptseljbhnweo	Gothenburg	Sweden

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	31.03.2021
Norway	Recruiting	31.03.2021
Sweden	Recruiting	31.03.2021

Trial locations

Investigated drugs:

Adenosine is a medication that helps to improve blood flow to the heart. In this trial, it is being used to see if it can help patients with Takotsubo Syndrome, a condition often referred to as “broken heart syndrome,” by improving their heart function and overall health outcomes.

Dipyridamole is a medication that works by keeping adenosine in the bloodstream longer, which can help improve blood flow to the heart. In this study, it is used alongside adenosine to see if the combination can provide better results for patients with Takotsubo Syndrome compared to the usual treatments.

Apixaban is a medication that helps prevent blood clots. In this trial, it is being tested to see if it can reduce the risk of blood clot-related events in patients with Takotsubo Syndrome, compared to not using any blood-thinning medications.

Takotsubo syndrome – Takotsubo syndrome is a temporary heart condition that often mimics a heart attack. It is characterized by sudden weakening of the heart muscle, leading to changes in the heart’s shape and function. The condition is often triggered by severe emotional or physical stress. During the syndrome, the heart’s main pumping chamber, the left ventricle, changes shape, resembling a Japanese octopus trap, which is where the name “Takotsubo” comes from. Symptoms can include chest pain, shortness of breath, and irregular heartbeats. The heart muscle typically recovers its normal function over time, but the condition can lead to complications if not monitored.

Trial ID:

2022-501874-21-00

Protocol code:

BROKEN-SWEDEHEART

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Adenosine, Dipyridamole, and Apixaban in Patients with Takotsubo Syndrome

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?