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
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.