Bisoprolol Adverse Reaction, Nebivolol Adverse Reaction
Conditions
Brief summary
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.
Interventions
DRUGBisoprolol versus Nebivolol
All subjects will receive both drugs, but at different time periods determined by randomization, with 1 week washout period
Sponsors
Clinical Hospital Center Zemun
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy subjects (male and female) 2. Age interval: 20-60 years old (inclusive)
Exclusion criteria
1. Any known absolute or relative contraindication to beta-blocker therapy 2. Poor echogenicity 3. A resting heart rate \<60 bpm 4. A resting blood pressure \< 110/70 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change (%) of cardiac output (CO) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute and relative changes of left ventricular ejection fraction (%) | Pre- and 5 hours post study drug administration | Ejection fraction will be measured using modified Simpson rule |
| Absolute and relative changes of global longitudinal strain (%) | Pre- and 5 hours post study drug administration | Global longitudinal strain will be assessed using speckle tracking echocardiography |
| Absolute and relative changes of myocardial work (%) | Pre- and 5 hours post study drug administration | Myocardial work will be assessed by using a dedicated commercially available software (GE, Norway) |
| Absolute and relative changes of atrial function (ml) | Pre- and 5 hours post study drug administration | Atrial function will be assessed by measuring phasic volume changes during diastole |
| Absolute change of myocardial dispersion (ms) | Pre- and 5 hours post study drug administration | Myocardial dispersion will be assessed by using speckle tracking echocardiography |
| Absolute and relative changes of TAPSE (tricuspid annular plane systolic excursion, mm) | Pre- and 5 hours post study drug administration | TAPSE will be assessed by M-mode echocardiography |
| Absolute and relative changes of blood pressure (mmHg) | Pre- and 5 hours post study drug administration | Brachial blood pressure will be measured by sphygmomanometer |
| Absolute and relative changes in atrial strain (%) | Pre- and 5 hours post study drug administration | Atrial strain will be assessed using speckle tracking echocardiography |
| Absolute and relative changes of electrical dispersion (ms) | Pre- and 5 hours post study drug administration | Electrical dispersion will be assessed by using 12-lead electrocardiogram |
| Absolute and relative changes of right ventricular fractional area change (%) | Pre- and 5 hours post study drug administration | The parameter will be assessed by two-dimensional echocardiography |
| Absolute and relative changes of heart rate (bpm) | Pre- and 5 hours post study drug administration | Heart rate will be measured by 12-lead electrocardiography |
| Absolute and relative changes of left ventricular twist (%) | Pre- and 5 hours post study drug administration | Twist will be assessed by speckle tracking echocardiography |
| Absolute and relative changes of QTc interval (ms) | Pre- and 5 hours post study drug administration | QTc interval will be measured by using 12-lead electrocardiography |
| Absolute and relative changes of mitral E/A ratio (%) | Pre- and 5 hours post study drug administration | E/A ratio will be assessed by pulsed-wave Doppler |
| Absolute and relative change of mitral E/e prime ratio (%) | Pre- and 5 hours post study drug administration | E/e prime ratio will be assessed by pulsed-wave and tissue Doppler echocardiography |
| Absolute and relative change of mitral E-wave deceleration time (ms) | Pre- and 5 hours post study drug administration | E-wave deceleration time will be measured by pulsed-wave Doppler echocardiography |
| Absolute and relative changes of right ventricular global longitudinal strain (%) | Pre- and 5 hours post study drug administration | Global strain will be assessed by using speckle tracking echocardiography |
Countries
Serbia
Outcome results
None listed