Hypertension Management and Cardiovascular Adverse Event Prevention in Patients with B-Cell Malignancies Undergoing Treatment with Bruton Tyrosine Kinase Inhibitors (HALT) - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of major adverse cardiovascular events (MACE)
研究概览
简要总结
This study evaluates the incidence and management of new and worsening high blood pressure in patients with B-cell cancers on BTKi treatment.
详细描述
PRIMARY OBJECTIVES:
I. To prospectively define the incidence of new and/or worsening HTN in patients with B-cell malignancies on BTKi.
II. To identify the hemodynamic changes associated with new and/or worsening HTN in patients with B-cell malignancies on BTKi by impedance cardiography (ICG) and thereby to define the optimal anti-hypertensive strategies.
III. To compare 1-year MACE rates between patients with B cell malignancies on BTKi with new or worsening HTN on optimal anti-HTN strategies with patients who do not develop HTN on BTKis.
OUTLINE: This is an observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Waldenstrom macroglobulinemia (WM), and marginal zone lymphoma (MZL), planned to begin Bruton tyrosine kinase inhibitors (BTKi) treatment or who will start a new BTKi agent after a 5-day wash out period (either as a single agent or on combination with other chemotherapies), who are willing to return to Mayo Clinic for ongoing follow-up
排除标准
- •Patients with known central nervous system (CNS) involvement of their B-cell malignancy
结局指标
主要结局
Incidence of major adverse cardiovascular events (MACE)
时间窗: Up to 12 months
1-year MACE rates between patients with B-cell malignancies on BTKi with new or worsening HTN on optimal anti-HTN strategies will be compared with patients who do not develop HTN on BTKi.
次要结局
- Incidence of new and/or worsening hypertension (HTN)(Up to 12 months)
- Hemodynamic changes associated with new and/or worsening HTN(Up to 12 months)
研究者
Joerg Herrmann, MD
Principal Investigator
Mayo Clinic