Tests beta-blockers in people with Takotsubo syndrome
Tests whether beta-blocker medicines help heart function in adults with Takotsubo syndrome.
Plain-language title generated from the registry record
Registry title: Beta-Blockers in Takotsubo Syndrome Study
Key facts
- Where
- Madrid, SpainSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Takotsubo syndrome (TTS) whose heart arteries were checked and showed no significant blockage. It tests whether beta-blockers help.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Diagnosis of TTS, with significant coronary artery disease ruled out by invasive coronary angiography. Diagnosed no more than 48 hours before.
- Earlier treatment
- People already on beta-blockers at a therapeutic dose when symptoms started cannot join.
Main reasons for not taking part
- TTS diagnosed more than 48 hours before
- Persistent cardiogenic shock or severe unstable circulation
- Persistent severe (>30 mmHg) intraventricular gradient
- Severe valve or heart muscle disease, or earlier heart attack due to coronary artery disease
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Where in Spain
- Hospital Universitario de la PrincesaMadrid, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Spanish Society of Cardiology
- Trial code
- NCT06509074
- Record updated
- 26 August 2024
- Original description
The Beta-blockers in Takotsubo syndrome (TTS) (β-Tako) trial, is an academic, pragmatic, prospective, multicenter randomized clinical trial, aiming to assess the efficacy of beta-blockers (BB) in TTS patients. Two-hundred patients with TTS will be randomized (1:1) to BB (n=100) or no BB (n=100). BB with alpha or nitric oxide release activity will be used in the treatment arm. The primary endpoint will be the comparison of the wall motion score index by echocardiography at 7 days. A composite clinical endpoint (death, stroke, admission for recurrent TTS, ACS, heart failure or atrial fibrillation) at 1 year, will be assessed by an independent clinical events committee. Several sub-studies will be performed. The β-Tako trial will inform treatment decisions in this uniquely challenging clinical entity.Read full original descriptionShow less
Beta-Blockers in Takotsubo Syndrome Study: A Randomized Clinical Trial (β-Tako)
The Beta-blockers in Takotsubo syndrome (TTS) (β-Tako) trial, is an academic, pragmatic, prospective, multicenter randomized clinical trial, aiming to assess the efficacy of beta-blockers (BB) in TTS patients. Two-hundred patients with TTS will be randomized (1:1) to BB (n=100) or no BB (n=100). BB with alpha or nitric oxide release activity will be used in the treatment arm. The primary endpoint will be the comparison of the wall motion score index by echocardiography at 7 days. A composite clinical endpoint (death, stroke, admission for recurrent TTS, ACS, heart failure or atrial fibrillation) at 1 year, will be assessed by an independent clinical events committee. Several sub-studies will be performed. The β-Tako trial will inform treatment decisions in this uniquely challenging clinical entity.
Inclusion: Written informed consent; Diagnosis of TTS with exclusion of significant coronary artery disease (CAD) by invasive coronary angiography.
Exclusion: Previous diagnosis of severe valvular or ventricular disease or prior myocardial infarction secondary to atherosclerotic CAD; Patients already receiving treatment with betablockers (*); Patients diagnosed of TTS > 48 hours before; Persistent ccardiogenic shock or severe hemodynamic instability; Persistent severe (>30 mmHg) intraventricular gradient; Absolute contraindication/indication for beta-blockers (**); Poor echocardiographic window; Pregnant or breastfeeding women; Participation in another clinical trial; (*) Betablockers at a therapeutic dose at the time of symptom´s onset. (**) Close ECG monitoring required in patients with hypotension, bradycardia or cQT interval prolongation.