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Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy

Primary Purpose

Hypertrophic Obstructive Cardiomyopathy

Status
Unknown status
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Esmolol
Placebo
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Obstructive Cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • E. Meshalkin National Medical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Esmolol

Placebo

Arm Description

1 mg/kg (max. 100 mg) as a bolus before aortic cross-clamping and 2 mg/kg (max. 200 mg) in the cardioplegia solution

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

Outcomes

Primary Outcome Measures

Peak concentration of Troponin I

Secondary Outcome Measures

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

Full Information

First Posted
May 19, 2021
Last Updated
October 6, 2021
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT05073094
Brief Title
Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy
Official Title
Myocardial Protection With Esmolol in Patients With Hypertrophic Obstructive Cardiomyopathy Undergoing Surgery Under Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Obstructive Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Esmolol
Arm Type
Experimental
Arm Description
1 mg/kg (max. 100 mg) as a bolus before aortic cross-clamping and 2 mg/kg (max. 200 mg) in the cardioplegia solution
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Equivalent volume of saline as a bolus before aortic cross-clamping and in the cardioplegic solution
Intervention Type
Drug
Intervention Name(s)
Esmolol
Intervention Description
Esmolol injected intravenously and added to cardioplegia solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Equivalent volume of placebo (saline) as a bolus before aortic cross-clamping and in the cardioplegic solution
Primary Outcome Measure Information:
Title
Peak concentration of Troponin I
Time Frame
From the randomization to the postoperative day 3 (POD 3)
Secondary Outcome Measure Information:
Title
The need for (yes/no) inotropic agents
Description
Number of patients requiring inotropic support
Time Frame
through study completion, an average of 4 weeks
Title
The need for (yes/no) defibrillation
Description
Number of patients requiring defibrlillation after removal of aortic cross clamp
Time Frame
through study completion, an average of 4 weeks
Title
The incidence of new-onset moderate and severe arrhythmias of cardiac arrest
Description
Number of patients with arrhythmias
Time Frame
through study completion, an average of 4 weeks
Title
Left ventricular ejection fraction
Time Frame
through study completion, an average of 4 weeks
Title
Peak serum creatinine concentration
Time Frame
through study completion, an average of 4 weeks
Title
The incidence of acute kidney injury
Time Frame
through study completion, an average of 4 weeks
Title
Duration of mechanical ventilation
Time Frame
through study completion, an average of 4 weeks
Title
Duration of ICU stay
Time Frame
through study completion, an average of 4 weeks
Title
Duration of hospital stay
Time Frame
through study completion, an average of 4 weeks
Title
30-day all-cause mortality
Time Frame
through study completion, an average of 4 weeks
Title
Presence of diastolic dysfunction
Time Frame
through study completion, an average of 4 weeks
Title
The dosage of inotropic agents (inotropic score)
Time Frame
through study completion, an average of 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir Lomivorotov
Phone
+79139164103
Email
vvlom@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Bogachev-Prokophiev
Email
bogachev.prokophiev@gmail.com
Facility Information:
Facility Name
E. Meshalkin National Medical Research Center
City
Novosibirsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Lomivorotov, MD
Email
vvlom@mail.ru

12. IPD Sharing Statement

Links:
URL
https://pubmed.ncbi.nlm.nih.gov/33451954/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/27932571/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/29398384/
Description
Related Info

Learn more about this trial

Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy

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