Beta-Blockers in Takotsubo Syndrome Study: A Randomized Clinical Trial (β-Tako)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Wall motion score index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors blinded to treatment allocation Blinded independent clinical event committee PROBE initiative
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Diagnosis of TTS with exclusion of significant coronary artery disease (CAD) by invasive coronary angiography
排除标准
- •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
研究组 & 干预措施
Beta-blockers
Beta-blockers with alpha or NO activity will be used. Dosage according to responsible physician and current clinical practice
干预措施: Beta blocker (Drug)
结局指标
主要结局
Wall motion score index
时间窗: 7 days
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)
次要结局
- Left ventricular ejection fraction(7 days)
- Delta (Change) in: wall motion score index, left ventricular ejection fraction, global longitudinal strain(1 month)
- Combined clinical endpoint (death, stroke, recurrent TTS, heart failure, acute coronary syndrome, atrial fibrillation(1 year)
- Angina and quality of life status during daily life assessed in routine clinical practice(1 year)
- Global longitudinal strain(7 days)
- 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(1 year)
研究者
Fernando Alfonso
Head Cardiac Department
Spanish Society of Cardiology