Echocardiographic Study of a Single Dose Bisoprolol Versus Nebivolol in Healthy Subjects

Bisoprolol Adverse Reaction Clinical Trial

— BINEB  

Official title:

Echocardiographic Study of a Single Dose Bisoprolol Versus Nebivolol in Healthy Subjects: a Randomized, Double-blind, Cross-over Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04432610
• Other study ID #: 01-2020
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2030
• Est. completion date: December 2030

Study information

• Verified date: December 2022
• Source: Clinical Hospital Center Zemun
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bisoprolol Adverse Reaction
• Nebivolol Adverse Reaction

Intervention

Drug:
• Bisoprolol versus Nebivolol
All subjects will receive both drugs, but at different time periods determined by randomization, with 1 week washout period

Locations

Country	Name	City	State
Serbia	Clinical Hospital Centre Zemun	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Center Zemun

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change (%) of cardiac output (CO)	CO (l/min), will be assessed by calculating stroke volume using pulsed-wave doppler (velocity time integral)	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative changes of left ventricular ejection fraction (%)	Ejection fraction will be measured using modified Simpson rule	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative changes of global longitudinal strain (%)	Global longitudinal strain will be assessed using speckle tracking echocardiography	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative changes of myocardial work (%)	Myocardial work will be assessed by using a dedicated commercially available software (GE, Norway)	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative changes of atrial function (ml)	Atrial function will be assessed by measuring phasic volume changes during diastole	Pre- and 5 hours post study drug administration
Secondary	Absolute change of myocardial dispersion (ms)	Myocardial dispersion will be assessed by using speckle tracking echocardiography	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative changes of TAPSE (tricuspid annular plane systolic excursion, mm)	TAPSE will be assessed by M-mode echocardiography	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative changes of blood pressure (mmHg)	Brachial blood pressure will be measured by sphygmomanometer	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative changes in atrial strain (%)	Atrial strain will be assessed using speckle tracking echocardiography	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative changes of electrical dispersion (ms)	Electrical dispersion will be assessed by using 12-lead electrocardiogram	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative changes of right ventricular fractional area change (%)	The parameter will be assessed by two-dimensional echocardiography	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative changes of heart rate (bpm)	Heart rate will be measured by 12-lead electrocardiography	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative changes of left ventricular twist (%)	Twist will be assessed by speckle tracking echocardiography	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative changes of QTc interval (ms)	QTc interval will be measured by using 12-lead electrocardiography	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative changes of mitral E/A ratio (%)	E/A ratio will be assessed by pulsed-wave Doppler	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative change of mitral E/e prime ratio (%)	E/e prime ratio will be assessed by pulsed-wave and tissue Doppler echocardiography	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative change of mitral E-wave deceleration time (ms)	E-wave deceleration time will be measured by pulsed-wave Doppler echocardiography	Pre- and 5 hours post study drug administration
Secondary	Absolute and relative changes of right ventricular global longitudinal strain (%)	Global strain will be assessed by using speckle tracking echocardiography	Pre- and 5 hours post study drug administration