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

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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 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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 2

    Initial assessment

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

  3. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

8 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Beta-Blockers – Beta-blockers are medications typically administered orally and are used to manage various heart conditions. In the context of Takotsubo Syndrome, an acute cardiac condition, beta-blockers are being evaluated for their effectiveness in aiding the recovery of left ventricular function. These medications work by blocking the effects of adrenaline on the heart, which helps to reduce heart rate and blood pressure, thereby decreasing the heart's workload. They are classified as antihypertensive agents and are commonly used in clinical practice for heart-related issues.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510213-25-01Protocol codeβ-TAKOEstimated enrolment200 patientsSponsorFundacion Casa Del Corazon

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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