Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 4

Conditions: Hypertrophic Obstructive Cardiomyopathy

Treatments: Drug: Placebo; Drug: Esmolol

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05073094

BETABLOCK-21

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Esmolol

Experimental group

Description:

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

Treatment:

Drug: Esmolol

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo