Beta-Blockers in Takotsubo Syndrome Study

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSpanish Society of Cardiology

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

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Spanish Society of Cardiology

Lead sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Collaborator