Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy

Sponsor

Meshalkin Research Institute of Pathology of Circulation (Other)

Overall Status

Recruiting

CT.gov ID

NCT05073094

Collaborator

(none)

Enrollment

Location

Arms

20.8

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertrophic Obstructive Cardiomyopathy	Drug: Esmolol Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 6, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 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

Drug: Esmolol

Esmolol injected intravenously and added to cardioplegia solution

Placebo Comparator: Placebo

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

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Peak concentration of Troponin I [From the randomization to the postoperative day 3 (POD 3)]

Secondary Outcome Measures

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
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
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	E. Meshalkin National Medical Research Center	Novosibirsk		Russian Federation

Sponsors and Collaborators

Meshalkin Research Institute of Pathology of Circulation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Meshalkin Research Institute of Pathology of Circulation

ClinicalTrials.gov Identifier:

NCT05073094

Other Study ID Numbers:

BETABLOCK-21

First Posted:

Oct 11, 2021

Last Update Posted:

Oct 11, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiomyopathies

Cardiomyopathy, Hypertrophic

Hypertrophy

Esmolol

Study Results

No Results Posted as of Oct 11, 2021