Beta-Blockers in Takotsubo Syndrome Study

Официальное название

Beta-Blockers in Takotsubo Syndrome Study: A Randomized Clinical Trial (β-Tako)

Обзор

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.

Подробное описание

Takotsubo syndrome (TTS) is a cardiac condition mimicking acute coronary syndrome (ACS), characterized by transient left ventricular (LV) dysfunction in the presence of normal coronary arteries. Its etiology remains unknown but reversible microvascular dysfunction secondary to an adrenergic surge appears implicated. Treatment is empiric although in clinical practice most patients receive beta-blockers (BB). The Beta-blockers in TTS (β-Tako) trial, is an academic, pragmatic, prospective, multicenter randomized clinical trial, aiming to assess the efficacy of BB in TTS patients. TTS diagnosis will be confirmed by invasive coronary angiography and serial echocardiographic studies. 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, analyzed in an independent corelab. Changes in LV ejection fraction and global longitudinal strain will be also evaluated. 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 (clinical, imaging, biomarkers, pharmacogenetic, mRNAs, quality of life) will be performed. The β-Tako trial will generate valuable scientific evidence to address unmet clinical needs and inform clinical and treatment decisions in this uniquely challenging clinical entity.

Вмешательства

• Препарат Beta blocker
  Pragmatic design. Any beta-blocker with alpha or NO activity may be used

Первичные конечные точки

• Wall motion score index [Срок оценки: 7 days]

Вторичные конечные точки (7)

• Left ventricular ejection fraction [Срок оценки: 7 days]
• Global longitudinal strain [Срок оценки: 7 days]
• Delta (Change) in: wall motion score index, left ventricular ejection fraction, global longitudinal strain [Срок оценки: 7 days]
• Delta (Change) in: wall motion score index, left ventricular ejection fraction, global longitudinal strain [Срок оценки: 1 month]
• Combined clinical endpoint (death, stroke, recurrent TTS, heart failure, acute coronary syndrome, atrial fibrillation [Срок оценки: 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 [Срок оценки: 1 year]
• Angina and quality of life status during daily life assessed in routine clinical practice [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Written informed consent.
• Diagnosis of TTS with exclusion of significant coronary artery disease (CAD) by invasive coronary angiography

Критерии исключения

• 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
• Patients already receiving treatment with betablockers (\*)
• Absolute contraindication/indication for beta-blockers (\*\*)
• Poor echocardiographic window
• Pregnant or breastfeeding women.
• Participation in another clinical trial.

(\*) Betablockers at a therapeutic dose at the time of symptom´s onset. (\*\*) Close ECG monitoring required in patients with hypotension, bradycardia or cQT interval prolongation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitario de la Princesa — Madrid

Публикации

• Alfonso F, Salamanca J, Nunez-Gil I, Ibanez B, Sanchis J, Sabate M, Velazquez M, Raposeiras-Roubin S, Garcia-Camarero T, Antuna P, Mejia H, Carrillo X, Buera I, Martinez-Selles M, Escudier-Villa JM, Sanchez-Prieto J, Blanco Ponce E, Cabezon G, Fernandez-Golfin C, Pascual-Figal D, Cid B, Marcano A, Gonzalez-Manzanares R, Jimenez-Valero S, Vazquez JM, Sanz-Sanchez J, Cecconi A, Del Val D, Abad-Santo PMID 39743172

Идентификаторы

NCT: NCT06509074 · 10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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