Innovative Biomarkers of Cardiovascular Complications Associated With Second-generation Bruton Tyrosine Kinase Inhibitor Treatments: a Single-center Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants with a diagnosis of new-onset high blood pressure or worsening of pre-existing hypertension
研究概览
简要总结
Second-generation Bruton's tyrosine kinase inhibitors (BTKIs) (zanubrutinib, acalabrutinib) are recently discovered oral targeted therapies used to treat hematological disorders such as chronic lymphocytic leukemia, mantle cell lymphoma, non-Hodgkin's lymphoma, and Waldenström's macroglobulinemia.
These treatments significantly increase survival rates for these diseases, but over the years, we have observed the emergence of cardiovascular adverse effects such as cardiac arrhythmia and high blood pressure, the type and frequency of which differ from those of first-generation drugs such as ibrutinib.
The frequency of these cardiovascular events remains poorly understood, as do the risk factors for developing these complications.
The aim of this study is to determine the exact incidence of cardiac arrhythmia and high blood pressure in patients receiving second-generation IBTK and to identify risk factors that can predict these complications through close, specialized monitoring.
Ultimately, this will make it possible to better target patients at highest risk of developing cardiovascular complications and offer them appropriate follow-up care.
This is a single-center, prospective, observational study conducted at the Dijon Bourgogne University Hospital.
The required number of subjects is 100 patients. The total follow-up period for each patient is one year.
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
- •Patients eligible for treatment with second-generation Bruton's tyrosine kinase inhibitors in hematology (acalabrutinib, zanubrutinib)
- •Patients aged 18 years and older
- •Patients who have given their free and informed written consent to participate in this study after receiving information (or the patient's representative if the patient is unable to express consent themselves).
- •Patients with a life expectancy estimated by the hematologist in charge of the patient to be greater than one year
排除标准
- •Persons not affiliated with or not covered by a social security system
- •Patients subject to legal protection measures (guardianship, trusteeship)
- •Patients subject to judicial protection measures
- •Pregnant women, women in labor, or breastfeeding women
- •Prior treatment with Bruton's tyrosine kinase inhibitors (ibrutinib, acalabrutinib, zanubrutinib)
- •Follow-up planned at another center
- •History of atrial fibrillation
- •Uncontrolled hypertension
研究组 & 干预措施
Patients
Patients eligible for treatment with second-generation Bruton's tyrosine kinase inhibitors in hematology (acalabrutinib, zanubrutinib)
干预措施: Ophthalmological examination (Other)
Patients
Patients eligible for treatment with second-generation Bruton's tyrosine kinase inhibitors in hematology (acalabrutinib, zanubrutinib)
干预措施: Blood sample (Biological)
结局指标
主要结局
Number of participants with a diagnosis of new-onset high blood pressure or worsening of pre-existing hypertension
时间窗: 12 months after initiation of treatment with second-generation Bruton's tyrosine kinase inhibitors in hematology
次要结局
未报告次要终点