Bisoprolol Adverse ReactionPhase 4BINEBNCT04432610
Echocardiographic Study of a Single Dose Bisoprolol Versus Nebivolol in Healthy Subjects
A Phase 4 study testing Bisoprolol versus Nebivolol in people with Bisoprolol Adverse Reaction and Nebivolol Adverse Reaction, run by Clinical Hospital Center Zemun at 1 site in Serbia.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bisoprolol Adverse Reaction, Nebivolol Adverse Reaction
- What is being tested?
- Bisoprolol versus Nebivolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSerbia
- Study dates
- Jan 2030to Dec 2030
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects (male and female)
- Age interval: 20-60 years old (inclusive)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Bisoprolol versus Nebivolol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bisoprolol versus NebivololDrug
All subjects will receive both drugs, but at different time periods determined by randomization, with 1 week washout period
| Study group | Role | What they receive |
|---|---|---|
| Bisoprolol first, Nebivolol Second | Experimental | In this arm, patient will first receive bisoprolol, and after 1 week washout period, nebivolol Receives: Drug: Bisoprolol versus Nebivolol |
| Nebivolol first, Bisoprolol second | Experimental | In this arm, patient will first receive nebivolol, and after 1 week washout period, bisoprolol Receives: Drug: Bisoprolol versus Nebivolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change (%) of cardiac output (CO)
CO (l/min), will be assessed by calculating stroke volume using pulsed-wave doppler (velocity time integral)
Measured: Pre- and 5 hours post study drug administration
Secondary outcomes (17)
Absolute and relative changes of left ventricular ejection fraction (%)
Ejection fraction will be measured using modified Simpson rule
Measured: Pre- and 5 hours post study drug administration
Absolute and relative changes of global longitudinal strain (%)
Global longitudinal strain will be assessed using speckle tracking echocardiography
Measured: Pre- and 5 hours post study drug administration
Absolute and relative changes of myocardial work (%)
Myocardial work will be assessed by using a dedicated commercially available software (GE, Norway)
Measured: Pre- and 5 hours post study drug administration
Absolute and relative changes of atrial function (ml)
Atrial function will be assessed by measuring phasic volume changes during diastole
Measured: Pre- and 5 hours post study drug administration
Absolute change of myocardial dispersion (ms)
Myocardial dispersion will be assessed by using speckle tracking echocardiography
Measured: Pre- and 5 hours post study drug administration
Absolute and relative changes of TAPSE (tricuspid annular plane systolic excursion, mm)
TAPSE will be assessed by M-mode echocardiography
Measured: Pre- and 5 hours post study drug administration
Absolute and relative changes of blood pressure (mmHg)
Brachial blood pressure will be measured by sphygmomanometer
Measured: Pre- and 5 hours post study drug administration
Absolute and relative changes in atrial strain (%)
Atrial strain will be assessed using speckle tracking echocardiography
Measured: Pre- and 5 hours post study drug administration
Absolute and relative changes of electrical dispersion (ms)
Electrical dispersion will be assessed by using 12-lead electrocardiogram
Measured: Pre- and 5 hours post study drug administration
Absolute and relative changes of right ventricular fractional area change (%)
The parameter will be assessed by two-dimensional echocardiography
Measured: Pre- and 5 hours post study drug administration
Absolute and relative changes of heart rate (bpm)
Heart rate will be measured by 12-lead electrocardiography
Measured: Pre- and 5 hours post study drug administration
Absolute and relative changes of left ventricular twist (%)
Twist will be assessed by speckle tracking echocardiography
Measured: Pre- and 5 hours post study drug administration
Absolute and relative changes of QTc interval (ms)
QTc interval will be measured by using 12-lead electrocardiography
Measured: Pre- and 5 hours post study drug administration
Absolute and relative changes of mitral E/A ratio (%)
E/A ratio will be assessed by pulsed-wave Doppler
Measured: Pre- and 5 hours post study drug administration
Absolute and relative change of mitral E/e prime ratio (%)
E/e prime ratio will be assessed by pulsed-wave and tissue Doppler echocardiography
Measured: Pre- and 5 hours post study drug administration
Absolute and relative change of mitral E-wave deceleration time (ms)
E-wave deceleration time will be measured by pulsed-wave Doppler echocardiography
Measured: Pre- and 5 hours post study drug administration
Absolute and relative changes of right ventricular global longitudinal strain (%)
Global strain will be assessed by using speckle tracking echocardiography
Measured: Pre- and 5 hours post study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study startJan 2030 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Why it stopped: COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bisoprolol Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Center Zemun
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Stankovic, Clinical Hospital Center Zemun
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432610
- Sponsor's protocol ID
- 01-2020
- Acronym
- BINEB
- Status last verified
- Dec 2022
- First submitted
- 9 Jun 2020
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Study of a Single Dose Bisoprolol Versus Nebivolol in Healthy Subjects: a Randomized, Double-blind, Cross-over Study
- ClinicalTrials.gov ID
- NCT04432610
- Acronym / sponsor ID
- BINEB / 01-2020
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Clinical Hospital Center ZemunUniversity, hospital or other
- Study start
- Jan 2030 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bisoprolol first, Nebivolol Second | Experimental | Drug: Bisoprolol versus NebivololIn this arm, patient will first receive bisoprolol, and after 1 week washout period, nebivolol |
| Nebivolol first, Bisoprolol second | Experimental | Drug: Bisoprolol versus NebivololIn this arm, patient will first receive nebivolol, and after 1 week washout period, bisoprolol |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects (male and female)
- Age interval: 20-60 years old (inclusive)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bisoprolol versus NebivololAll subjects will receive both drugs, but at different time periods determined by randomization, with 1 week washout period | Drug | Bisoprolol first, Nebivolol Second, Nebivolol first, Bisoprolol second |
Primary outcome
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)
17 secondary outcomes
Absolute and relative changes of left ventricular ejection fraction (%)
Time frame: 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
Absolute and relative changes of myocardial work (%)
Time frame: 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
Absolute change of myocardial dispersion (ms)
Time frame: 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
Absolute and relative changes of blood pressure (mmHg)
Time frame: 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
Absolute and relative changes of electrical dispersion (ms)
Time frame: 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
Absolute and relative changes of heart rate (bpm)
Time frame: 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
Absolute and relative changes of QTc interval (ms)
Time frame: 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
Absolute and relative change of mitral E/e prime ratio (%)
Time frame: 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
Absolute and relative changes of right ventricular global longitudinal strain (%)
Time frame: Pre- and 5 hours post study drug administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bisoprolol versus Nebivolol in people with Bisoprolol Adverse Reaction and Nebivolol Adverse Reaction, run by Clinical Hospital Center Zemun at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change (%) of cardiac output (CO) (time frame: Pre- and 5 hours post study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.