CTIS2022-501874-21-00招募中1 期
Optimized pharmacological treatment for broken heart (takotsubo) syndrome - BROKEN-SWEDEHEART
Vastra Gotalandsregionen0 个研究点目标入组 1,600 人开始时间: 2022年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Age equal or above 18 years, 2. A clinical diagnosis of Takotsubo Syndrome, including an ejection fraction (EF) <50% at baseline, 3. Written informed consent obtained
排除标准
- •Previous randomization in the study, Previously diagnosed left ventrilular ejaction fraction lower than 50%, Known cardiomyopathy (except previous Takotsubo Syndrome), Known hemodynamically significant valve disease (moderate or severe aortic/mitral regurgitation or stenosis), Heart transplant or left ventricular assist device recipient, Most recent (within the most recent 3 moths) haemoglobin lower than 100 g/L, Any concomitant condition resulting in a life expectancy of less than one month, Systolic blood pressure lower than 80 mm Hg at screening, Estimated glomerular filtration rate lower than 30 mL/min/1.73 m2, Current dialysis, Pregnancy or of childbearing potential who is not steralized or is not using a medically accepted form of contraception, Not suitable in the opinion of the investigator due to severe or terminal comorbidity with poor prognosis, or characteristics that may interfere with adherence to the study-protocol, Specific exclusion criteria for randomization 2 as following: 1.Any contra-indication for anticoagulant treatment. 2.Current indication for treatment with, anticoagulant or dual antiplatelet therapy 3.Declined participation in study 2., Specific exclusion criteria for randomization 1 as following: 1 Any contra-indication for treatment with adenosine or dipyridamole (including AV-block II and III, sick-sinus syndrome in subjects who don´t have a functioning pacemaker, unstable angina, ongoing treatment with dipyridamole) 2. Severe asthma (defined as asthma requiring medium or high-dose inhaled corticosteroids combined with other long-acting medications) and severe Chronic Obstructive Pulmonary Disease (COPD), (defined as FEV-1 ? 50 %) 3. Ongoing treatment with dipyridamole. 4 Declined participation in study 1., Any concomitant condition resulting in a life expectancy of less than one month
研究者
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