A Prospective, Multi-center, Randomized, Open-label, Clinical Trial to Compare the Aortic Pulse Pressure Effects of Bisoprolol and Atenolol in 12 Weeks Treatment of Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- Change From Baseline in Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12
研究概览
简要总结
Antihypertensive drugs aim to reduce blood pressure (BP) either through decrease of the total peripheral resistance through vasodilatation at the level of arterioles (microcirculation) or by decreasing the cardiac output through reduction of the stroke volume or heart rate or both. On the other hand, all antihypertensive drugs might potentially decrease arterial stiffness passively with the reduction of the distending pressure or with the resynchronization of the reflected pressure wave. With theses potential mechanisms, it is also expected that these drugs might exert a favorable effect on pulse pressure amplification between central and peripheral arteries.
However, there is solid evidence that the widely applied antihypertensive drugs have differential effect on brachial and central BP. Several reports in the past have confirmed the potential hypothesis that beta blockers decrease central BP less than the observed reduction at the level of the brachial artery. It has been hypothesized that deceleration of heart rate and the re synchronizing the reflected pressure wave earlier in the systolic phase seems to be the leading cause of non-favorable effect of beta blockers on central BP, these effects might be partially counterbalanced in beta blockers with high beta-1 selectivity resulting in less peripheral vasoconstriction properties.
详细描述
Central pulse pressure is a better predictor of left ventricular mass and carotid intima thickness, and the conventional peripheral BP does not seem to be an accurate reflection of central arterial BP. The pulse pressure amplification between peripheral and central arteries reflects the left ventricular afterload, subendothelial viability, and the intensity of cyclic stress imposed to the renal and cerebral micro- and macro vessels. As central hemodynamic parameters are independently associated with organ damage and are closely related to important cardiovascular outcome, it is suggested that the new clinical trials on antihypertensive drug treatment should compare simultaneously the chronic effect of drugs on both peripheral and central BP.
OBJECTIVES
Primary objective:
- To assess the effect of bisoprolol versus atenolol on the aortic pulse pressure as a central hemodynamic index in subjects with hypertension
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An antihypertensive-naive subject or a subject who has not been taking the previously administered antihypertensive agent for at least 4 weeks prior to screening
- •Subjects aged between 20 and 75 years, inclusive
- •Subjects with systolic blood pressure (SBP) greater than or equal to 140 millimeter of mercury (mmHg) and less than 180 mmHg or diastolic blood pressure (DBP) greater than or equal to 90 mmHg and less than 110 mmHg
排除标准
- •Subjects with secondary hypertension
- •Subjects with renal impairment (Creatinine greater than 150 micromoles/liter [mcmol/L] or Creatinine greater than 1.7 mg/deciliter [dL])
- •Subjects with severe hypertension (Stage III) SBP greater than or equal to 180 mmHg or DBP greater than or equal to 110 mmHg
- •Subjects with congestive heart failure, acute myocardial infarction, unstable angina
- •Subjects with moderate bronchial asthma, chronic obstructive pulmonary disease
- •Subjects with symptomatic bradycardia, radial artery injury, second degree or third degree atrioventricular (AV) block, atrial fibrillation, atrial flutter, left bundle branch block (LBBB)
- •Subjects with a history of hypersensitivity to bisoprolol and atenolol products
- •Pregnancy or breastfeeding women
研究组 & 干预措施
Bisoprolol
干预措施: Bisoprolol (Drug)
Atenolol
干预措施: Atenolol (Drug)
结局指标
主要结局
Change From Baseline in Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12
时间窗: Baseline and Week 12
The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.
Change From Baseline in Aortic Pulse Pressure (APP) in Per Protocol (PP) Population at Week 12
时间窗: Baseline and Week 12
The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.
次要结局
- Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12(Baseline, Week 4 and Week 12)
- Change From Baseline in Aortic Augmentation Index (AIx) at Week 4 and Week 12(Baseline, Week 4 and Week 12)
- Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 4 and Week 12(Baseline, Week 4 and Week 12)
- Change From Baseline in Heart Rate at Week 4 and Week 12(Baseline, Week 4 and Week 12)
- Change From Baseline in Aortic Pulse Pressure (APP) at Week 4(Baseline and Week 4)
- Change From Baseline in Lipid Levels at Week 12(Baseline and Week 12)
- Change From Baseline in Blood Glucose Levels at Week 12(Baseline and Week 12)
- Change From Baseline in Brachial Blood Pressure (BP) at Week 4 and Week 12(Baseline, Week 4 and Week 12)
- Number of Participants With Adverse Events (AEs)(Baseline up to Week 14 (follow-up visit))