2024-515060-32-00招募中3 期
A Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Levosimendan Therapy in low ejection fraction Takotsubo Syndrome (LevoTako Trial)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 13
- 主要终点
- In-hospital LVEF recovery
研究概览
简要总结
To evaluate whether off-label use of levosimendan accelerates in-hospital left ventricular ejection fraction (LVEF) recovery and reduces the 12-month incidence of all-cause mortality or major adverse cardiovascular events (MACE) — including rehospitalization due to Takotsubo syndrome (TTS) recurrence or heart failure, stroke, or transient ischemic attack (TIA) — in patients with TTS and an LVEF ≤40% at admission, compared to placebo.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age > 60 years - Current hospitalization due to TTS - LVEF as assessed by echocardiography within 24 hours of admission ≤ 40% or decrease in LVEF by ≥ 10% compared to the last documented LVEF value before index hospitalization - NTproBNP concentration ≥ 500 pg/mL
排除标准
- •Myocardial infarction within 30 days before randomization
- •Cerebrovascular disease (new stroke, subarachnoid hemorrhage)
- •Diagnosis of pheochromocytoma
- •Diagnosis of myocarditis
- •Low output syndrome - hypotonia with signs of tissue hypoperfusion (systolic blood pressure < 85 mmHg AND lactate > 2 mmol/L) XML File Identifier: oaQaRqf974zsAHLIB5CKhj434nk= Page 10/22
- •Pulmonary edema
- •Echocardiographic evidence of LVOTO
- •Uncontrolled hypertension
- •Planned revascularization or surgical treatment of heart failure within the next 12 months
- •Advanced chronic kidney disease (eGFR < 30 mL/min.)
- •Biochemical features of liver damage (>5 upper limits of reference hepatic aminotransferase activity and/or >3 upper limits of reference total bilirubin level)
- •Severe chronic lung disease with features of respiratory failure [defined as respiratory dysfunction impairing gas exchange and leading to hypoxemia - arterial blood oxygen partial pressure (PaO2) <60mmHg (8.0 kPa) and/or hypercapnia - increase in carbon dioxide partial pressure (PaCO2) ≥45mmHg (6, 0 kPa)] or severe spirometry abnormalities [defined as very severe obstruction, i.e., a decrease in the forced expiratory volume in 1 second (FEV1) <35% of normal value] or home oxygen therapy [in chronic lung disease with features of respiratory failure, indications for home oxygen therapy include: PaO2 ≤55 mmHg (corresponding to saturation ≤88%); PaO2 55-60 mmHg (corresponding to saturation ≤88%); and pulmonary hypertension, peripheral edema suggestive of right heart failure, or polycythemia (hematocrit>55%)].
- •Concomitant chronic disease with poor prognosis (e.g., cancer)
- •Paroxysmal supraventricular tachycardia, paroxysmal ventricular tachycardia including torsade de pointes, severe atrioventricular block within one month before the study eligibility visit
- •History of hypersensitivity to levosimendan
- •Pregnancy or postpartum period
- •Patients with foreseeable problems cooperating with the medical and nursing team.
结局指标
主要结局
In-hospital LVEF recovery
In-hospital LVEF recovery
次要结局
- Composite endpoint including 12-month all-cause mortality or major adverse cardiovascular events rate (rehospitalization due to TTS recurrence or heart failure, stroke or TIA, whatever occurs first)
研究者
Chief Medical Officer; Principal Investigator
Scientific
Medical University Of Gdansk
研究点 (13)
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