About this trial
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.
Eligibility criteria
Qualifiers
Written informed consent.
Diagnosis of TTS with exclusion of significant coronary artery disease (CAD) by invasive coronary angiography
Disqualifiers
Patients diagnosed of TTS > 48 hours before.
Persistent ccardiogenic shock or severe hemodynamic instability
Persistent severe (>30 mmHg) intraventricular gradient
Previous diagnosis of severe valvular or ventricular disease or prior myocardial infarction secondary to atherosclerotic CAD
Trial design
Treatments tested in this trial
- Beta blocker
Treatment groups
Sponsors and collaborators
Spanish Society of Cardiology
Lead sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Collaborator