Echocardiographic Study of a Single Dose Bisoprolol Versus Nebivolol in Healthy Subjects: a Randomized, Double-blind, Cross-over Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Relative change (%) of cardiac output (CO)
研究概览
简要总结
This is a randomized, double-blind, crossover study in healthy adult subjects. Each subject will receive a single dose of bisoprolol 5 mg p.o. and nebivolol 5 mg p.o. with 1 week washout period. All subjects will undergo a physical examination, 12-lead electrocardiography and a comprehensive echocardiographic study before the administration of the study drug and 5 hours thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects (male and female)
- •Age interval: 20-60 years old (inclusive)
排除标准
- •Any known absolute or relative contraindication to beta-blocker therapy
- •Poor echogenicity
- •A resting heart rate <60 bpm
- •A resting blood pressure < 110/70 mmHg
研究组 & 干预措施
Bisoprolol first, Nebivolol Second
In this arm, patient will first receive bisoprolol, and after 1 week washout period, nebivolol
干预措施: Bisoprolol versus Nebivolol (Drug)
Nebivolol first, Bisoprolol second
In this arm, patient will first receive nebivolol, and after 1 week washout period, bisoprolol
干预措施: Bisoprolol versus Nebivolol (Drug)
结局指标
主要结局
Relative change (%) of cardiac output (CO)
时间窗: Pre- and 5 hours post study drug administration
CO (l/min), will be assessed by calculating stroke volume using pulsed-wave doppler (velocity time integral)
次要结局
- Absolute and relative changes of blood pressure (mmHg)(Pre- and 5 hours post study drug administration)
- Absolute and relative changes of QTc interval (ms)(Pre- and 5 hours post study drug administration)
- Absolute and relative changes of mitral E/A ratio (%)(Pre- and 5 hours post study drug administration)
- Absolute and relative change of mitral E/e prime ratio (%)(Pre- and 5 hours post study drug administration)
- Absolute and relative changes of atrial function (ml)(Pre- and 5 hours post study drug administration)
- Absolute and relative changes of TAPSE (tricuspid annular plane systolic excursion, mm)(Pre- and 5 hours post study drug administration)
- Absolute and relative changes of left ventricular twist (%)(Pre- and 5 hours post study drug administration)
- Absolute and relative changes of right ventricular global longitudinal strain (%)(Pre- and 5 hours post study drug administration)
- Absolute and relative changes of left ventricular ejection fraction (%)(Pre- and 5 hours post study drug administration)
- Absolute and relative changes of global longitudinal strain (%)(Pre- and 5 hours post study drug administration)
- Absolute and relative changes of myocardial work (%)(Pre- and 5 hours post study drug administration)
- Absolute change of myocardial dispersion (ms)(Pre- and 5 hours post study drug administration)
- Absolute and relative changes in atrial strain (%)(Pre- and 5 hours post study drug administration)
- Absolute and relative changes of electrical dispersion (ms)(Pre- and 5 hours post study drug administration)
- Absolute and relative changes of right ventricular fractional area change (%)(Pre- and 5 hours post study drug administration)
- Absolute and relative changes of heart rate (bpm)(Pre- and 5 hours post study drug administration)
- Absolute and relative change of mitral E-wave deceleration time (ms)(Pre- and 5 hours post study drug administration)
研究者
Ivan Stankovic
Head of Echocardiography
Clinical Hospital Center Zemun