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

Phase 4

Withdrawn

• Conditions: Bisoprolol Adverse Reaction; Nebivolol Adverse Reaction
• Interventions: Drug: Bisoprolol versus Nebivolol

• Registration Number: NCT04432610
• Lead Sponsor: Clinical Hospital Center Zemun

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20
• Study Start: 2030-01
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nebivolol first, Bisoprolol second	Bisoprolol versus Nebivolol	In this arm, patient will first receive nebivolol, and after 1 week washout period, bisoprolol
Bisoprolol first, Nebivolol Second	Bisoprolol versus Nebivolol	In this arm, patient will first receive bisoprolol, and after 1 week washout period, nebivolol

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 atrial function (ml)	Pre- and 5 hours post study drug administration	Atrial function will be assessed by measuring phasic volume changes during diastole
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 left ventricular twist (%)	Pre- and 5 hours post study drug administration	Twist will be assessed by speckle tracking 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
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 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 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 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 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

Trial Locations

Locations (1)

Clinical Hospital Centre Zemun; 🇷🇸 Belgrade, Serbia