Alfonso Fernando, Salamanca Jorge, Núñez-Gil Iván, Ibáñez Borja, Sanchis Juan, Sabaté Manel, Velázquez Maite, Raposeiras-Roubín Sergio, García-Camarero Tamara, Antuña Paula, Mejía Hernán, Carrillo Xavier, Buera Irene, Martínez-Sellés Manuel, Escudier-Villa Juan Manuel, Sánchez-Prieto Joaquín, Blanco Ponce Emilia, Cabezón Gonzalo, Fernández-Golfín Covadonga, Pascual-Figal Domingo, Cid Belén, Marcano Ana, González-Manzanares Rafael, Jiménez-Valero Santiago, Vázquez José Manuel, Sanz-Sánchez Jorge, Cecconi Alberto, Del Val David, Abad-Santos Francisco, Crea Filippo
Servicio de Cardiología, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria de La Princesa (IIS-IP), Universidad Autónoma de Madrid, Madrid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
Servicio de Cardiología, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria de La Princesa (IIS-IP), Universidad Autónoma de Madrid, Madrid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
Rev Esp Cardiol (Engl Ed). 2024 Dec 30. doi: 10.1016/j.rec.2024.12.006.
Tako-tsubo syndrome (TTS) is a cardiac condition that mimics acute coronary syndrome, characterized by transient left ventricular dysfunction in the absence of culprit coronary artery stenosis. Although its etiology remains unknown, reversible microvascular dysfunction secondary to an adrenergic surge is thought to play a role. Treatment is empirical, although most patients receive beta-blockers (BB) in clinical practice. The Beta-blockers in Tako-tsubo Syndrome study (β-Tako), is an academic, multicenter, pragmatic, prospective randomized open-label trial with blinded endpoint evaluation that aims to assess the efficacy and safety of BB in patients with TTS.
The diagnosis of TTS will be confirmed by invasive coronary angiography and serial echocardiographic assessments. 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 efficacy endpoint is the comparison of the wall motion score index by echocardiography at 7 days, analyzed by an independent core laboratory. Changes in left ventricular ejection fraction and global longitudinal strain will also be evaluated. A composite clinical endpoint (death, stroke, admission for recurrent TTS, acute coronary syndrome, heart failure, or atrial fibrillation) at 1 year will be assessed by an independent clinical events committee. Several predefined substudies will be conducted to examine clinical, imaging, biomarker, pharmacogenetic, inflammatory, messenger ribonucleic acids, and quality-of-life parameters.
The β-Tako trial will generate robust scientific evidence to address unmet clinical needs and inform clinical and treatment decisions in this uniquely challenging clinical entity. The study has been registered (EU-CT number: 2023-510213-25-01, ClinicalTrials.gov Identifier, NCT06509074.
应激性心肌病（TTS）是一种模仿急性冠状动脉综合征的心脏疾病，其特征是在没有罪犯冠状动脉狭窄的情况下出现短暂的左心室功能障碍。尽管其病因尚不清楚，但继发于肾上腺素能激增的可逆性微血管功能障碍被认为起了作用。治疗是经验性的，尽管在临床实践中大多数患者接受β受体阻滞剂（BB）治疗。应激性心肌病中的β受体阻滞剂研究（β-Tako）是一项学术性、多中心、务实、前瞻性随机开放标签试验，采用盲法终点评估，旨在评估BB对TTS患者的疗效和安全性。
TTS的诊断将通过有创冠状动脉造影和系列超声心动图评估来确认。200例TTS患者将被随机（1:1）分为接受BB治疗组（n = 100）或不接受BB治疗组（n = 100）。治疗组将使用具有α或一氧化氮释放活性的BB。
主要疗效终点是由独立核心实验室分析的7天时超声心动图测得的壁运动评分指数的比较。还将评估左心室射血分数和整体纵向应变的变化。独立临床事件委员会将评估1年时的复合临床终点（死亡、中风、因复发性TTS、急性冠状动脉综合征、心力衰竭或心房颤动入院）。将进行几项预定义的亚研究，以检查临床、影像学、生物标志物、药物遗传学、炎症、信使核糖核酸和生活质量参数。
β-Tako试验将产生有力的科学证据，以满足未满足的临床需求，并为这一极具挑战性的临床实体的临床和治疗决策提供依据。该研究已注册（欧盟临床试验编号：2023 - 510213 - 25 - 01，ClinicalTrials.gov标识符，NCT06509074）。
