Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy

NCT ID: NCT05073094

Last Updated: 2021-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-06

Study Completion Date

2023-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertrophic Obstructive Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Esmolol

1 mg/kg (max. 100 mg) as a bolus before aortic cross-clamping and 2 mg/kg (max. 200 mg) in the cardioplegia solution

Group Type EXPERIMENTAL

Esmolol

Intervention Type DRUG

Esmolol injected intravenously and added to cardioplegia solution

Placebo

Equivalent volume of saline as a bolus before aortic cross-clamping and in the cardioplegic solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Equivalent volume of placebo (saline) as a bolus before aortic cross-clamping and in the cardioplegic solution

Interventions

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Esmolol

Esmolol injected intravenously and added to cardioplegia solution

Intervention Type DRUG

Placebo

Equivalent volume of placebo (saline) as a bolus before aortic cross-clamping and in the cardioplegic solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Signed informed consent
* Patient with hypertrophic obstructive cardiomyopathy undergoing surgery under cardiopulmonary bypass

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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E. Meshalkin National Medical Research Center

Novosibirsk, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Vladimir Lomivorotov

Role: CONTACT

+79139164103

Alexander Bogachev-Prokophiev

Role: CONTACT

Facility Contacts

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Vladimir Lomivorotov, MD

Role: primary

Related Links

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Other Identifiers

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BETABLOCK-21

Identifier Type: -

Identifier Source: org_study_id

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