Beta-Blockers in Takotsubo Syndrome: A Randomized Clinical Trial

INTERVENTION: Product Name: ‐,Product Code: C07AB,Pharmaceutical Form: ,Other descriptive name: ,Strength: ‐,Product Name: ‐,Product Code: C07AG,Pharmaceutical Form: ,Other descriptive name: ,Strength: ‐,Product Name: ‐,Product Code: C07AA,Pharmaceutical Form: ,Other descriptive name: ,Strength: ‐ CONDITION: MedDRA version: 20.0Level: LLTClassification code: 10066332Term: Acute cardiac insufficiencySystem Organ Class: 10007541 MedDRA version: 20.1Level: LLTClassification code: 10067676Term: Takotsubo syndromeSystem Organ Class: 10007541 Takotsubo Syndrome (TT) is an acute cardiac condition ; MedDRA version: 20.0Level: LLTClassification code: 10066332Term: Acute cardiac insufficiencySystem Organ Class: 10007541 ; MedDRA version: 20.1Level: LLTClassification code: 10067676Term: Takotsubo syndromeSystem Organ Class: 10007541 Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective:To evaluate the clinical efficacy of the most widely used pharmacological therapeutic strategy in patients with Takotsubo Syndrome (TT) in clinical practice. Namely, to assess the role of beta‐blockers with alpha activity or nitric oxide liberation, to facilitate left ventricular function recovery on echocardiography in TT patients. The consistency of the treatment effect will be examined among several predefined relevant clinical subgroups after adjusting for multiple comparisons. Primary end point(s):Comparison of left ventricular systolic function recovery as assessed by the echocardiographic left ventricular wall motion score index (WMSI) at 7 days. Secondary Objective:Several secondary objectives will be also addressed using well‐defined predefined ancillary studies. The main prospective systematic sub‐studies include: 1) Assessment of other relevant echocardiographic outcome measures of left ventricular function (LVEF, GLS) at different time points after the index event, 2) Coronary angiographic assessment (visual and QCA), 3) Magnetic resonance imaging (MRI), 4) Intracoronary imaging (optical coherence tomography [OCT] and intravascular ultrasound [IVUS], 5) Invasive and noninvasive coronary physiological indexes, 6) Cardiac CT, 6), 7) Pharmacogenetics, 8) Inflammatory, immunologic, genetic and micro‐RNA analyses, and 9) Quality of life (QoL) analyses (using classical, well accepted, questionnaires). SECONDARY OUTCOME: Secondary end point(s):A) Changes in left ventricular function by other methods (LVEF and GLS). B) Comparison of clinical outcomes (adverse clinical events). INCLUSION CRITERIA: • Written informed consent. • Diagnosis of TT (+) with exclusion of significant culprit coronary artery disease by invasive angiography (++)