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Study on Beta-Blockers for Patients with Takotsubo Syndrome: Evaluating Selective, Non-Selective, and Alpha-Beta Blocking Agents

3 1 1 1

What is this study about?

This clinical trial is focused on studying Takotsubo Syndrome, an acute heart condition. The study will explore the effectiveness of different types of medications known as beta-blockers. These medications are commonly used to help the heart function better. The trial will include three types of beta-blockers: selective beta-blockers like nebivolol and metoprolol, non-selective beta-blockers such as propranolol, and beta-blockers with alpha activity like carvedilol. These medications are taken orally, meaning they are swallowed in pill form.

The purpose of the study is to evaluate how well these beta-blockers help the heart recover in patients with Takotsubo Syndrome. The study will last for up to 24 weeks, during which participants will receive one of the beta-blockers or a placebo. The main focus will be on observing the improvement in heart function using a test called an echocardiogram, which uses sound waves to create images of the heart. This will help doctors see how well the heart is pumping blood.

Throughout the study, the effects of the treatment will be monitored to see if there are any changes in heart function and to check for any side effects. The results will help determine the best treatment approach for patients with Takotsubo Syndrome, aiming to improve their heart health and overall well-being.

1 joining the study

Participation begins after providing written informed consent.

Eligibility requires a diagnosis of Takotsubo Syndrome confirmed by specific tests, excluding significant coronary artery disease.

2 initial assessment

An initial assessment of heart function is conducted using echocardiography to establish a baseline for the study.

3 medication administration

Participants receive beta-blockers, which are medications that help manage heart conditions. These are taken orally.

The specific type of beta-blocker used in this study may have additional properties, such as alpha activity or nitric oxide release, to aid heart function recovery.

4 monitoring and follow-up

Heart function is monitored regularly through echocardiography to track recovery progress.

The primary focus is on the improvement of the heart’s pumping ability, measured by the left ventricular wall motion score index at 7 days.

5 evaluation of outcomes

Secondary evaluations include changes in heart function using other methods and monitoring for any adverse clinical events.

The study aims to determine the effectiveness of the treatment across different patient groups.

6 completion of the study

The study is expected to conclude by February 2026, with all data collected and analyzed to assess the treatment’s efficacy.

Who Can Join the Study?

  • Must provide written informed consent, which means you agree to participate in the study after being fully informed about it.
  • Must have a diagnosis of Takotsubo Syndrome (TT), a sudden heart condition.
  • Must not have significant blockage in the heart’s blood vessels, confirmed by a procedure called invasive angiography, which is a test that uses a special dye and X-rays to see how blood flows through the heart.
  • Both men and women can participate.
  • Participants can be from different age groups, including adults and older adults.

Who Cannot Join the Study?

  • Patients who have a different heart condition that is not related to Takotsubo Syndrome.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of severe allergic reactions to medications used in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a serious illness that might interfere with the study, such as advanced cancer.
  • Patients who are unable to follow the study procedures or attend follow-up visits.
  • Patients who have a history of substance abuse that could affect their ability to participate in the study.
  • Patients who have a mental health condition that might interfere with their ability to understand the study or give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Clinico Universitario De Valladolid Valladolid Spain
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
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Hpzctmow Uajjcbczfiswt Mpyicle Dq Vmzsqpdklr Santander Spain
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Hsnjeyps Du Ln Syvro Cmhb I Szhe Pdq Barcelona Spain
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
15.03.2024

Trial locations

Beta-Blockers are medications commonly used to manage heart conditions. In this trial, they are being tested for their effectiveness in helping patients with Takotsubo Syndrome, a temporary heart condition often brought on by stress. These medications work by slowing down the heart rate and reducing the heart’s workload, which may help the heart recover its normal function. The trial is specifically looking at beta-blockers that have additional properties, such as alpha activity or the ability to release nitric oxide, to see if they offer extra benefits in improving heart function in patients with this syndrome.

Takotsubo Syndrome – Takotsubo Syndrome is an acute cardiac condition that often mimics a heart attack. It is characterized by a sudden weakening of the heart muscle, leading to changes in the heart’s shape and function. This syndrome is typically triggered by severe emotional or physical stress. Patients may experience chest pain and shortness of breath, similar to symptoms of a heart attack. The condition usually involves a temporary dysfunction of the left ventricle, the heart’s main pumping chamber. Over time, the heart muscle generally recovers its normal function.

Trial ID:
2023-510213-25-01
Protocol code:
β-TAKO
Trial Phase:
Therapeutic confirmatory (Phase III)

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