Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy

Study Overview
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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.

Official Title
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Myocardial Protection With Esmolol in Patients With Hypertrophic Obstructive Cardiomyopathy Undergoing Surgery Under Cardiopulmonary Bypass

Conditions
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Hypertrophic Obstructive Cardiomyopathy

Intervention / Treatment
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* Drug: Esmolol
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esmolol<br>1 mg/kg (max. 100 mg) as a bolus before aortic cross-clamping and 2 mg/kg (max. 200 mg) in the cardioplegia solution | Drug: Esmolol<br>* Esmolol injected intravenously and added to cardioplegia solution<br>|
| Placebo Comparator: Placebo<br>Equivalent volume of saline as a bolus before aortic cross-clamping and in the cardioplegic solution | Drug: Placebo<br>* Equivalent volume of placebo (saline) as a bolus before aortic cross-clamping and in the cardioplegic solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak concentration of Troponin I |  | From the randomization to the postoperative day 3 (POD 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The need for (yes/no) inotropic agents | Number of patients requiring inotropic support | 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 | 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 | through study completion, an average of 4 weeks | 
| 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 | 
| Duration of mechanical ventilation |  | through study completion, an average of 4 weeks | 
| Duration of ICU stay |  | 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 |