NCT04407845Unknown不适用
Etude de l'Incidence et Des Facteurs prédictifs de la Survenue de Fibrillation Atriale Sous Ibrutinib
European Georges Pompidou Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年5月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of cardiovascular events on ibrutinib
研究概览
简要总结
Ibrutinib (a tyrosine kinase inhibitor targeting Bruton) is a standard of treatment in haematology. According to retrospective data, atrial fibrillation and systemic hypertension are common ibrutinib-related advserse events. The investigators aim at prospectively establishing the incidence of thesedrug related advsere events through clinical monitoring and attempt at identifying populations at risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All patients deem to start ibrutinib therapy
排除标准
- •Past history of ibrutinib therapy
结局指标
主要结局
Incidence of cardiovascular events on ibrutinib
时间窗: 6 months
Evaluate the incidence of cardiotoxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of ibrutinib.
次要结局
- Incidence of hemorraghe(6 months)
- Incidence of supra-ventricular arrythmias(6 months)
- Incidence of systemic hypertension(6 months)
- Incidence of arterial embolism(6 months)
- Safety mesures(1 year)
- Anticoagulants(1 year)
研究者
Mariana Mirabel
MD, PhD, Associate Professor
European Georges Pompidou Hospital
研究点 (1)
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