A Multicenter, Prospective Cohort Study for Detection of Cardiotoxicities in Patients Receiving Ibrutinib or Acalabrutinib for CLL
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Incidence of atrial arrhythmias
研究概览
简要总结
This is a multicenter, prospective, observational cohort study to comprehensively and longitudinally evaluate and characterizes the cardiovascular events with CLL patients who are initiating treatment with a Bruton's tyrosine kinase (BTK) inhibitor ibrutinib or acalabrutinib.
详细描述
This research study includes three visits for research blood, physical exam, and cardiac testing at baseline, 3 months, and 6 months. The study will collect the following data during the 6-month study period:
- Blood sample collection
- Electrocardiogram (ECG)
- Echocardiogram
- Cardiac magnetic resonance imaging (MRI)
- Mobile cardiac telemetry
- Blood pressure measurement
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of atrial arrhythmias
时间窗: During 6 months of BTK inhibitor therapy
Any documented evidence of atrial arrhythmia including symptomatic and asymptomatic events captured by EKG, 28-day mini cardiac telemetry, or monitoring of cardiac rhythm during echocardiogram or cardiac MRI.
次要结局
- Severity of ventricular arrythmia(During 6 months of BTK inhibitor therapy)
- Incidence of ventricular arrhythmias(During 6 months of BTK inhibitor therapy)
研究者
Inhye Ahn
Principal Investigator
Dana-Farber Cancer Institute