Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Patients With Essential Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 2
- 主要终点
- Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal
研究概览
简要总结
This is a Phase 4, prospective, multi-centric and randomized controlled study to compare the effects of bisoprolol and atenolol on resting heart rate (RHR) and sympathetic nervous system's (SNS) activity in subjects with essential hypertension.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 25-65 years
- •Subjects with essential hypertension (EH)
- •Subjects with systolic blood pressure (SBP) 140-160 millimeter of mercury (mmHg) and diastolic blood pressure (DBP) 90-100 mmHg
- •Subjects with normal sinus rhythm
- •Subjects with resting heart rate (RHR) greater than 70 bpm
- •Subjects who give written informed consent
排除标准
- •Subjects with atrial fibrillation (AF)/sick sinus syndrome (SSS)/atrioventricular block II-III Grade (AVB II-III) without pacemaker
- •Subjects with bradyarrhythmia/hypotension
- •Subjects with unstable angina pectoris (UAP)/acute myocardial infarction (AMI)/heart failure (HF) (New York Heart Association [NYHA] Class III - IV)
- •Subjects with uncontrolled diabetes mellitus (DM)
- •Subjects with bronchial asthma
- •Subjects with gastro-intestinal ulcer or skin ulcer
- •Subjects with liver dysfunction/renal impairment
- •Subjects treated with calcium channel blockers (except amlodipine) or other beta-blockers.
- •Subjects with glaucoma
- •Subjects with known allergic/intolerance to beta-blocker
- •Pregnant or lactating women
- •Subjects who had participated in another clinical study within the last 3 months
- •Subjects who have legal incapacity or limited legal capacity
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 Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal
时间窗: Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6)
Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 beats per minute (bpm).
Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up
时间窗: Baseline and end of follow-up (Week 4 or Week 6 or Week 8)
Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
次要结局
- Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up(Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8))
- Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment(Baseline up to attainment of heart rate goal (Week 2 or Week 4 or Week 6))
- Change From Baseline in Ratio of Heart Rate Variability (HRV) for Low Frequency Power (LF) to Heart Rate Variability Power (HRV) for High Frequency (HF) (LF/HF) at Attainment of Heart Rate Goal and End of Follow-up(Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8))
- Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6(Attainment of heart rate goal (Week 2 or Week 4 or Week 6))
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to end of follow-up (Week 4 or Week 6 or Week 8))
- Number of Participants Compliant With Study Treatment(Baseline up to end of follow-up (Week 4 or Week 6 or Week 8))