Beta-Blockers in Takotsubo Syndrome Study
NCT Number: NCT06509074
Acronym: β-Tako
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Takotsubo Cardiomyopathy|Beta-blockers|Echocardiography|Left Ventricular Function
Interventions: DRUG: Beta blocker
Sponsor: Spanish Society of Cardiology
Collaborators: Hospital Universitario de La Princesa (Madrid, Spain)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-12
Locations: Hospital Universitario de la Princesa, Madrid, 28006, Spain

Summary:
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.

Primary Outcome Measures: Wall motion score index, Wall motion score index by echocardiography to assess recovery of left ventricular function Wall motion score index (WMSI) ranges from 1 to 4 (1 is normal and 4 worse), 7 days
Secondary Outcome Measures: Left ventricular ejection fraction, Left ventricular ejection fraction by echocardiography to assess recovery of left ventricular function, 7 days|Global longitudinal strain, Global longitudinal strain by echocardiography to assess recovery of left ventricular function, 7 days|Delta (Change) in: wall motion score index, left ventricular ejection fraction, global longitudinal strain, Changes in LV function by imaging, 7 days|Delta (Change) in: wall motion score index, left ventricular ejection fraction, global longitudinal strain, Changes in LV function by imaging, 1 month|Combined clinical endpoint (death, stroke, recurrent TTS, heart failure, acute coronary syndrome, atrial fibrillation, Combined clinical endpoint, 1 year|Individual endpoints of the combined clinical endpoint Occurrence of death, stroke, recurrent TT, heart failure, acute coronary syndrome, atrial fibrillation will be analyzed and compared individually, Individual clinical endpoints Occurrence of death, stroke, recurrent TT, heart failure, acute coronary syndrome, atrial fibrillation will be analyzed and compared individually in the 2 groups, 1 year|Angina and quality of life status during daily life assessed in routine clinical practice, Evaluated in clinical visits, 1 year
Other Outcome Measures: Cardiac Magnetic Resonance (CMR), CMR to detect edema, late gadolinium enhancement to correlate with clinical data and prognosis, 1 year|ECG, Correlation of ECG findings with clinical features and prognosis Different ECG parameters will be correlated with the echocardiographic and clinical outcome measures to detect potential correlations, 1 year|Pharmacogenetic substudy, To assess pharmacogenetic implications of different beta-blockers used The pharcacogenetics of the 2 different betablockers used in this study will be studied in relation to the main echocardiographic and clinical endpoints, 1 year|Coronary angiography, To assess correlation with angiographic features and clinical findings and prognosis, 1 year|Biomarkers, inflammatory data, mRNAs, Association with clinical findings and prognosis, 1 year