Hypertrophic Obstructive CardiomyopathyPhase 4NCT05073094
Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy
A Phase 4 study testing Esmolol in people with Hypertrophic Obstructive Cardiomyopathy, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Perioperative blockage of beta-adrenoreceptors is widely used in cardiac and non-cardiac surgery to reduce the rate of cardiovascular complications. Several randomized-controlled studies and meta-analysis showed that esmolol reduces the incidence of myocardial ischemia and arrhythmias in cardiac surgery as well as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Obstructive Cardiomyopathy
- What is being tested?
- Esmolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 6 Oct 2021to 1 Jul 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Signed informed consent
- Patient with hypertrophic obstructive cardiomyopathy undergoing surgery under cardiopulmonary bypass
Who cannot join
- History of adverse effects on esmolol
- Urgent/emergent surgery
- Administration of esmolol in 30 days before randomization
- Participation in other randomized trial during same hospitalization
Trial locations and contacts
1 site in 1 country.
Alexander Bogachev-Prokophiev contact
Russia1 site, 1 recruiting
- Recruiting
E. Meshalkin National Medical Research Center
Novosibirsk
Vladimir Lomivorotov, MD, vvlom@mail.ru
About this study
Official title: Myocardial Protection With Esmolol in Patients With Hypertrophic Obstructive Cardiomyopathy Undergoing Surgery Under Cardiopulmonary Bypass
Perioperative blockage of beta-adrenoreceptors is widely used in cardiac and non-cardiac surgery to reduce the rate of cardiovascular complications. Several randomized-controlled studies and meta-analysis showed that esmolol reduces the incidence of myocardial ischemia and arrhythmias in cardiac surgery as well as enhances postoperative cardiac performance. No studies assessed the influence of esmolol in patients with hypertrophic obstructive cardiomyopathy undergoing cardiac surgery.
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Being tested
- Esmolol, Placebo
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
Esmolol injected intravenously and added to cardioplegia solution
PlaceboDrug
Equivalent volume of placebo (saline) as a bolus before aortic cross-clamping and in the cardioplegic solution
| Study group | Role | What they receive |
|---|---|---|
| Esmolol | Experimental | 1 mg/kg (max. 100 mg) as a bolus before aortic cross-clamping and 2 mg/kg (max. 200 mg) in the cardioplegia solution Receives: Drug: Esmolol |
| Placebo | Placebo comparator | Equivalent volume of saline as a bolus before aortic cross-clamping and in the cardioplegic solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration of Troponin I
Measured: From the randomization to the postoperative day 3 (POD 3)
Secondary outcomes (12)
The need for (yes/no) inotropic agents
Number of patients requiring inotropic support
Measured: through study completion, an average of 4 weeks
The need for (yes/no) defibrillation
Number of patients requiring defibrlillation after removal of aortic cross clamp
Measured: through study completion, an average of 4 weeks
The incidence of new-onset moderate and severe arrhythmias of cardiac arrest
Number of patients with arrhythmias
Measured: through study completion, an average of 4 weeks
Left ventricular ejection fraction
Measured: through study completion, an average of 4 weeks
Peak serum creatinine concentration
Measured: through study completion, an average of 4 weeks
The incidence of acute kidney injury
Measured: through study completion, an average of 4 weeks
Duration of mechanical ventilation
Measured: through study completion, an average of 4 weeks
Duration of ICU stay
Measured: through study completion, an average of 4 weeks
Duration of hospital stay
Measured: through study completion, an average of 4 weeks
30-day all-cause mortality
Measured: through study completion, an average of 4 weeks
Presence of diastolic dysfunction
Measured: through study completion, an average of 4 weeks
The dosage of inotropic agents (inotropic score)
Measured: through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start6 Oct 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Obstructive CardiomyopathyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073094
- Sponsor's protocol ID
- BETABLOCK-21
- Status last verified
- Oct 2021
- First submitted
- 19 May 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Protection With Esmolol in Patients With Hypertrophic Obstructive Cardiomyopathy Undergoing Surgery Under Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT05073094
- Acronym / sponsor ID
- BETABLOCK-21
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 11 Oct 2021 (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.
Perioperative blockage of beta-adrenoreceptors is widely used in cardiac and non-cardiac surgery to reduce the rate of cardiovascular complications. Several randomized-controlled studies and meta-analysis showed that esmolol reduces the incidence of myocardial ischemia and arrhythmias in cardiac surgery as well as enhances postoperative cardiac performance. No studies assessed the influence of esmolol in patients with hypertrophic obstructive cardiomyopathy undergoing cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esmolol | Experimental | Drug: Esmolol1 mg/kg (max. 100 mg) as a bolus before aortic cross-clamping and 2 mg/kg (max. 200 mg) in the cardioplegia solution |
| Placebo | Placebo comparator | Drug: PlaceboEquivalent volume of saline as a bolus before aortic cross-clamping and in the cardioplegic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Signed informed consent
- Patient with hypertrophic obstructive cardiomyopathy undergoing surgery under cardiopulmonary bypass
Key exclusion criteria (4 listed)
- History of adverse effects on esmolol
- Urgent/emergent surgery
- Administration of esmolol in 30 days before randomization
- Participation in other randomized trial during same hospitalization
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 |
|---|---|---|
| EsmololEsmolol injected intravenously and added to cardioplegia solution | Drug | Esmolol |
| PlaceboEquivalent volume of placebo (saline) as a bolus before aortic cross-clamping and in the cardioplegic solution | Drug | Placebo |
Primary outcome
Peak concentration of Troponin I
Time frame: From the randomization to the postoperative day 3 (POD 3)
12 secondary outcomes
The need for (yes/no) inotropic agents
Time frame: through study completion, an average of 4 weeks
The need for (yes/no) defibrillation
Time frame: through study completion, an average of 4 weeks
The incidence of new-onset moderate and severe arrhythmias of cardiac arrest
Time frame: through study completion, an average of 4 weeks
Left ventricular ejection fraction
Time frame: through study completion, an average of 4 weeks
Peak serum creatinine concentration
Time frame: through study completion, an average of 4 weeks
The incidence of acute kidney injury
Time frame: through study completion, an average of 4 weeks
Duration of mechanical ventilation
Time frame: through study completion, an average of 4 weeks
Duration of ICU stay
Time frame: through study completion, an average of 4 weeks
Duration of hospital stay
Time frame: through study completion, an average of 4 weeks
30-day all-cause mortality
Time frame: through study completion, an average of 4 weeks
Presence of diastolic dysfunction
Time frame: through study completion, an average of 4 weeks
The dosage of inotropic agents (inotropic score)
Time frame: through study completion, an average of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Alexander Bogachev-Prokophiev contact
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 Esmolol in people with Hypertrophic Obstructive Cardiomyopathy, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Oct 2021. 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 Russia. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Lomivorotov (+79139164103, vvlom@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak concentration of Troponin I (time frame: From the randomization to the postoperative day 3 (POD 3)). 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 11 Oct 2021.