2024-514743-28-00招募中2 期
GeranylGeranylAcetone as prevention for postoperative Atrial Fibrillation (GENIALITY)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Assessment of Postoperative atrial fibrillation incidence, by Holter monitoring
研究概览
简要总结
To prevent incidence of postoperative atrial fibrillation on patients undergoing cardiothoracic surgery
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 80 years old
- •Elected for cardiothoracic surgery for mitral valve stenosis or regurgitation, and/or aortic valve stenosis or regurgitation, and/or coronary artery disease
排除标准
- •Documented history of AF
- •Not able to undergo the complete study protocol
- •Previous cardiothoracic surgery
- •Doubt about compliance
- •Pre-menopausal women who are nursing, pregnant, or of child-bearing potential
- •Chronic malabsorption
- •Any documented or suspected malignancy or history of malignancy within 1 year prior to screening, except appropriate treated basal cell carcinoma or in situ carcinoma of the cervix
- •Currently enrolled in another drug trial
结局指标
主要结局
Assessment of Postoperative atrial fibrillation incidence, by Holter monitoring
Assessment of Postoperative atrial fibrillation incidence, by Holter monitoring
次要结局
- The secondary trial endpoints are assessments of activation of HSPs by biochemical analysis and microscopic imaging; in blood, atrial tissue and epicardial adipose tissue
研究者
Principal Investigator
Scientific
Stichting Amsterdam UMC
研究点 (1)
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