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

NCT04432610 | Withdrawn Phase 4

• 1 other identifier: 01-2020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bisoprolol Adverse Reaction; Nebivolol Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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 and relative changes of atrial function (ml)

  Pre- and 5 hours post study drug administration

• Absolute change of myocardial dispersion (ms)

  Pre- and 5 hours post study drug administration

Study Arms (2)

Bisoprolol first, Nebivolol Second

EXPERIMENTAL

In this arm, patient will first receive bisoprolol, and after 1 week washout period, nebivolol

Drug: Bisoprolol versus Nebivolol

Nebivolol first, Bisoprolol second

EXPERIMENTAL

In this arm, patient will first receive nebivolol, and after 1 week washout period, bisoprolol

Drug: Bisoprolol versus Nebivolol

Interventions

Bisoprolol versus Nebivolol DRUG

All subjects will receive both drugs, but at different time periods determined by randomization, with 1 week washout period

Bisoprolol first, Nebivolol Second; Nebivolol first, Bisoprolol second

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects (male and female)
• Age interval: 20-60 years old (inclusive)

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Center Zemun: lead

Study Sites (1)

Clinical Hospital Centre Zemun

Belgrade, 11080, Serbia

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Echocardiography

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start (Estimated): January 1, 2030
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)