Rapid Recovery of Left Ventricular Function in Patients With Takotsubo Syndrome Undergoing Systemic Infusion of Adenosine: a Randomized Controlled Trial (TITAN Study)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- left ventricle ejection fraction (%)
研究概览
简要总结
The investigators will randomize patients admitted to hospital with Takotsubo diagnosis to systematic high-dose adenosine infusion for 3 minutes (in addition to standard of care) vs. standard of care. The primary aim of the study is to demonstrate that adenosine infusion is associated with a larger and more rapid recovery of left ventricle function.
详细描述
Takotsubo syndrome is a heart condition that is characterized by the rapid onset of left ventricular dysfunction, usually reversible, and meeting the following diagnostic criteria:
- Transient alterations of regional contractility of the myocardial wall of the right or left ventricle, which are frequently, but not always, preceded by a stressful event (emotional or physical).
- The regional changes in contractility of the myocardial wall, often extend beyond the distribution of a single coronary vessel, and often result in a circumferential ventricular dysfunction of the involved segments.
- Absence of a culprit coronary lesion (eg. Of atherosclerotic plaque rupture, thrombus formation, coronary dissection) or other pathological conditions that may explain the regional changes in contractility of the myocardial wall (eg. Hypertrophic cardiomyopathy, viral myocarditis)
- Reversible electrocardiographic abnormalities of the EKG (ST-T segment elevation or depression, new onset of left bundle branch block, inversion of t wave and / or QTc elongation) during the acute phase (3 months).
- Significant increase in serum natriuretic peptide (BNP or NT-proBNP) during the acute phase
- Troponin significant increase, but relatively small, (disparity between the degree of left ventricular dysfunction and the value of troponin).
- The recovery of left ventricular function during follow-up (3-6 months).
Epidemiology Since the Takotsubo syndrome has been described for the first time in 1991, its incidence, with the passing of years has been increasing, thanks to the possibility with networks for the treatment of acute myocardial infarction, to have a early access to coronary angiography study. Currently this syndrome accounts for 2% of all acute coronary syndromes who are undergoing coronary angiography.
Pathophysiology The pathophysiology of Takotsubo syndrome is complex, and not fully clarified. There are several causes have been suggested over the years to explain the occurrence of this syndrome (vascular and / or myocardial). One of the mechanisms suggested is that there is a systemic response, by the body, to a severe stress which causes a sudden increase of catecholamines endogenous and exogenous; this increase has an effect on the cardiovascular system leading to acute heart failure.
Stress is one of the most common causes behind the onset of this syndrome, and emotional stress (eg. Mourning,quarrel, etc.) and physical (eg. Surgical emergencies, obstetric or psychiatric), but it is not always a present condition.
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 (Participant)
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
- •18 years old
- •Evidence of typical anatomical pattern to the left ventriculography (total akinesia of the mid-apical segments with hypercontractility basal segments) associated with the presence of criteria for the diagnosis of Takotsubo syndrome (Table 1)
- •signing of informed consent
排除标准
- •allergy to adenosine
- •known and documented diagnosis of asthma
- •pre-existing ischemic heart disease
- •presence of arrhythmic complication (AV block grade II type 2 and third degree)
研究组 & 干预措施
Saline solution
Patients in this arm will receive systemic infusion of saline solution at 140μg/kg/min for 3 minutes plus standard therapy according to current guidelines
干预措施: Saline solution (Drug)
Adenosine
Patients in this arm will receive systemic infusion of adenosine at 140μg/kg/min for 3 minutes plus standard therapy according to current guidelines
干预措施: Adenosine (Drug)
结局指标
主要结局
left ventricle ejection fraction (%)
时间窗: 48 hours
an indipendent corelab will review all images from 48-hour ecocardiography to establish LVEF value (%)
次要结局
- emergency room admission(1 month)
- left ventricle ejection fraction (%)(1 month)
- wall motion score index(1 month)
- acute heart failure(1 month)
- intravenous diuretics(1 month)
- major adverse events(1 year)
- hypokinetic arrhythmias(1 hour)
- arterial hypotension(1 hour)
- side effects(1 hour)
研究者
Gianluca Campo
Associate Professor
University Hospital of Ferrara
