Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy

Hypertrophic Obstructive Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05073094
• Other study ID #: BETABLOCK-21
• Status: Recruiting
• Phase: Phase 4
• Start date: October 6, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: October 2021
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Vladimir Lomivorotov
• Phone: +79139164103
• Email: vvlom[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Obstructive Cardiomyopathy
• Hypertrophy

Intervention

Drug:
• Esmolol
Esmolol injected intravenously and added to cardioplegia solution
• Placebo
Equivalent volume of placebo (saline) as a bolus before aortic cross-clamping and in the cardioplegic solution

Locations

Country	Name	City	State
Russian Federation	E. Meshalkin National Medical Research Center	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak concentration of Troponin I		From the randomization to the postoperative day 3 (POD 3)
Secondary	The need for (yes/no) inotropic agents	Number of patients requiring inotropic support	through study completion, an average of 4 weeks
Secondary	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
Secondary	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
Secondary	Left ventricular ejection fraction		through study completion, an average of 4 weeks
Secondary	Peak serum creatinine concentration		through study completion, an average of 4 weeks
Secondary	The incidence of acute kidney injury		through study completion, an average of 4 weeks
Secondary	Duration of mechanical ventilation		through study completion, an average of 4 weeks
Secondary	Duration of ICU stay		through study completion, an average of 4 weeks
Secondary	Duration of hospital stay		through study completion, an average of 4 weeks
Secondary	30-day all-cause mortality		through study completion, an average of 4 weeks
Secondary	Presence of diastolic dysfunction		through study completion, an average of 4 weeks
Secondary	The dosage of inotropic agents (inotropic score)		through study completion, an average of 4 weeks

External Links

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