Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy

Phase 4

• Conditions: Hypertrophic Obstructive Cardiomyopathy
• Interventions: Drug: Placebo; Drug: Esmolol

• Registration Number: NCT05073094
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief 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 enhances postoperative cardiac performance. No studies assessed the influence of esmolol in patients with hypertrophic obstructive cardiomyopathy undergoing cardiac surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-19
• Status Verified: 2021-10
• Study Start: 2021-10-06
• Study First Submitted QC: 2021-10-06
• Last Update Submitted: 2021-10-06
• Study First Posted: 2021-10-11
• Last Update Posted: 2021-10-11
• Primary Completion: 2023-06-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Equivalent volume of saline as a bolus before aortic cross-clamping and in the cardioplegic solution
Esmolol	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

Primary Outcome Measures

Name	Time	Method
Peak concentration of Troponin I	From the randomization to the postoperative day 3 (POD 3)

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	through study completion, an average of 4 weeks
Duration of hospital stay	through study completion, an average of 4 weeks
30-day all-cause mortality	through study completion, an average of 4 weeks
Presence of diastolic dysfunction	through study completion, an average of 4 weeks
The dosage of inotropic agents (inotropic score)	through study completion, an average of 4 weeks
The need for (yes/no) inotropic agents	through study completion, an average of 4 weeks	Number of patients requiring inotropic support
The need for (yes/no) defibrillation	through study completion, an average of 4 weeks	Number of patients requiring defibrlillation after removal of aortic cross clamp
Left ventricular ejection fraction	through study completion, an average of 4 weeks
Peak serum creatinine concentration	through study completion, an average of 4 weeks
The incidence of acute kidney injury	through study completion, an average of 4 weeks
The incidence of new-onset moderate and severe arrhythmias of cardiac arrest	through study completion, an average of 4 weeks	Number of patients with arrhythmias
Duration of ICU stay	through study completion, an average of 4 weeks

Trial Locations

Locations (1)

E. Meshalkin National Medical Research Center; 🇷🇺 Novosibirsk, Russian Federation