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

December 19, 2022 updated by: Ivan Stankovic, Clinical Hospital Center Zemun

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11080
        • Clinical Hospital Centre Zemun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bisoprolol first, Nebivolol Second
In this arm, patient will first receive bisoprolol, and after 1 week washout period, nebivolol
Drug: Bisoprolol versus Nebivolol
All subjects will receive both drugs, but at different time periods determined by randomization, with 1 week washout period
Experimental: Nebivolol first, Bisoprolol second
In this arm, patient will first receive nebivolol, and after 1 week washout period, bisoprolol
Drug: Bisoprolol versus Nebivolol
All subjects will receive both drugs, but at different time periods determined by randomization, with 1 week washout period

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relative change (%) of cardiac output (CO)
Time Frame: 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)
Pre- and 5 hours post study drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absolute and relative changes of left ventricular ejection fraction (%)
Time Frame: Pre- and 5 hours post study drug administration
Ejection fraction will be measured using modified Simpson rule
Pre- and 5 hours post study drug administration
Absolute and relative changes of global longitudinal strain (%)
Time Frame: Pre- and 5 hours post study drug administration
Global longitudinal strain will be assessed using speckle tracking echocardiography
Pre- and 5 hours post study drug administration
Absolute and relative changes of myocardial work (%)
Time Frame: Pre- and 5 hours post study drug administration
Myocardial work will be assessed by using a dedicated commercially available software (GE, Norway)
Pre- and 5 hours post study drug administration
Absolute and relative changes of atrial function (ml)
Time Frame: Pre- and 5 hours post study drug administration
Atrial function will be assessed by measuring phasic volume changes during diastole
Pre- and 5 hours post study drug administration
Absolute change of myocardial dispersion (ms)
Time Frame: Pre- and 5 hours post study drug administration
Myocardial dispersion will be assessed by using speckle tracking echocardiography
Pre- and 5 hours post study drug administration
Absolute and relative changes of TAPSE (tricuspid annular plane systolic excursion, mm)
Time Frame: Pre- and 5 hours post study drug administration
TAPSE will be assessed by M-mode echocardiography
Pre- and 5 hours post study drug administration
Absolute and relative changes of blood pressure (mmHg)
Time Frame: Pre- and 5 hours post study drug administration
Brachial blood pressure will be measured by sphygmomanometer
Pre- and 5 hours post study drug administration
Absolute and relative changes in atrial strain (%)
Time Frame: Pre- and 5 hours post study drug administration
Atrial strain will be assessed using speckle tracking echocardiography
Pre- and 5 hours post study drug administration
Absolute and relative changes of electrical dispersion (ms)
Time Frame: Pre- and 5 hours post study drug administration
Electrical dispersion will be assessed by using 12-lead electrocardiogram
Pre- and 5 hours post study drug administration
Absolute and relative changes of right ventricular fractional area change (%)
Time Frame: Pre- and 5 hours post study drug administration
The parameter will be assessed by two-dimensional echocardiography
Pre- and 5 hours post study drug administration
Absolute and relative changes of heart rate (bpm)
Time Frame: Pre- and 5 hours post study drug administration
Heart rate will be measured by 12-lead electrocardiography
Pre- and 5 hours post study drug administration
Absolute and relative changes of left ventricular twist (%)
Time Frame: Pre- and 5 hours post study drug administration
Twist will be assessed by speckle tracking echocardiography
Pre- and 5 hours post study drug administration
Absolute and relative changes of QTc interval (ms)
Time Frame: Pre- and 5 hours post study drug administration
QTc interval will be measured by using 12-lead electrocardiography
Pre- and 5 hours post study drug administration
Absolute and relative changes of mitral E/A ratio (%)
Time Frame: Pre- and 5 hours post study drug administration
E/A ratio will be assessed by pulsed-wave Doppler
Pre- and 5 hours post study drug administration
Absolute and relative change of mitral E/e prime ratio (%)
Time Frame: Pre- and 5 hours post study drug administration
E/e prime ratio will be assessed by pulsed-wave and tissue Doppler echocardiography
Pre- and 5 hours post study drug administration
Absolute and relative change of mitral E-wave deceleration time (ms)
Time Frame: Pre- and 5 hours post study drug administration
E-wave deceleration time will be measured by pulsed-wave Doppler echocardiography
Pre- and 5 hours post study drug administration
Absolute and relative changes of right ventricular global longitudinal strain (%)
Time Frame: Pre- and 5 hours post study drug administration
Global strain will be assessed by using speckle tracking echocardiography
Pre- and 5 hours post study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinical Hospital Center Zemun

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2030

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2030

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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