Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy

October 6, 2021 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vladimir Lomivorotov
  • Phone Number: +79139164103
  • Email: vvlom@mail.ru

Study Contact Backup

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation
        • Recruiting
        • E. Meshalkin National Medical Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

October 6, 2021

First Posted (Actual)

October 11, 2021

Study Record Updates

Last Update Posted (Actual)

October 11, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BETABLOCK-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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