A 25 Week, Open Label Study to Determine the Effects of Nebivolol When Added to Hydrochlorothiazide on Diastolic Function and Arterial Stiffness in African Americans With Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in systolic and diastolic blood pressure after treatment with nebivolol and reaching normal blood pressure <140/90
研究概览
简要总结
The main purpose of this study is to evaluate the effects of Nebivolol and Hydrochlorothiazide on blood pressure in African Americans with high blood pressure.
详细描述
Many blood pressure medications are not effective in African American men and women. The two lower chambers of the heart contract to pump blood to the body. The lower chambers have to relax so they can refill with blood to pump out again. Many patients with high blood pressure have stiffness in the lower chambers which prevents the heart from relaxing so it can properly fill with blood. Some patients with the stiffness in the lower chambers of the heart will develop heart failure.
The study is to test whether or not Nebivolol (Bystolic)and a diuretic Hydrochlorothiazide (HCTZ) will help the heart relax so the heart can properly fill and prevent stiffness of the lower heart chambers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Known Hypertension by history
- •Self-described African American
排除标准
- •Uncontrolled Diabetes Mellitus (HbA1C>10)
- •Known CAD, Cerebrovascular Disease, PVD or Renovascular Disease
- •Liver disease
- •Chronic Renal Disease
- •Uncontrolled Hypertension (>199 systolic and/or >115)
研究组 & 干预措施
Arm A
Nebivolol to reach blood pressure control
干预措施: Nebivolol (Drug)
Arm B
Hydrochlorothiazide for blood pressure control
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Changes in systolic and diastolic blood pressure after treatment with nebivolol and reaching normal blood pressure <140/90
时间窗: Every visit for 25 weeks (9 study visits)
次要结局
- Differences after nebivolol treatment on diastolic function as measured by tissue doppler imaging (ECHO), arterial compliance and stiffness and vascular nitric oxide availability determined by neutrophil function(At the begining and end of study)