Comparative Blood Pressure Effects of Nebivolol Versus Lisinopril in Patients With New Onset or Exacerbated Hypertension Induced by Bevacizumab: a Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study will be changes in sitting systolic and diastolic blood pressure at the crossover and final visits.
研究概览
简要总结
The purpose of this study is to directly compare the blood pressure (hypertension) reduction effects of lisinopril and nebivolol in patients who develop new onset or worsening hypertension while treated with bevacizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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 currently treated at the University of Mississippi Medical Center Oncology Clinic
- •Patient is being treated with bevacizumab either alone or in combination with other agents for cancer
- •Patient blood pressure is >140 mmHg (systolic) or > 90 mmHg (diastolic), either treated or untreated with medications for hypertension
- •Patients may be currently on medications for hypertension (other than Beta blocker, ACEI, or ARB); these will be continued at the same dose throughout the study
- •Patients should be > 18 years of age
- •Patients receiving bevacizumab therapy approximately every 2 weeks
排除标准
- •History of ACEI or ARB induced angioedema or idiopathic/hereditary angioedema
- •Patient currently treated with a Beta blocker, ACEI, or ARB or have a history of intolerance to a medication in any of these classes
- •Hyperkalemia, defined as a potassium value of >5 mEq/L
- •Pregnancy or breastfeeding
- •Severe renal impairment (eGFR <30 mL/min)
- •Moderate hepatic impairment as identified by physician
- •Currently taking CYP2D6 inducers (rifampin, carbamazepine or dexamethasone) or inhibitors (bupropion, fluoxetine, paroxetine, duloxetine, etc.)
- •History of clinically significant EKG abnormality which would contraindicate beta blocker use
- •Recent stroke (<6 months)
- •Recent myocardial infarction (<6 months)
- •Congestive heart failure
- •Severe asthma or COPD
- •Diagnosed obstructive sleep apnea
研究组 & 干预措施
Nebivolol
Nebivolol 5 mg daily for 2 weeks, then 5 or 10 mg daily for 2 weeks
干预措施: Nebivolol (Drug)
Lisinopril
20 mg once daily for 2 weeks, then 20 or 40 mg once daily for 2 weeks
干预措施: Lisinopril (Drug)
结局指标
主要结局
The primary endpoint of the study will be changes in sitting systolic and diastolic blood pressure at the crossover and final visits.
时间窗: 8 weeks
Patients will be treated with both nebivolol or lisinopril for a period of 4 weeks, and then crossover to the opposite medication for an additional 4 weeks.
次要结局
- The secondary endpoint of the study will be changes in heart rate at the end of the crossover and final visits.(8 weeks)
研究者
Zachery Somers
PharmD
University of Mississippi Medical Center