Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy

NCT05073094 | Unknown Phase 4

• 1 other identifier: BETABLOCK-21
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Obstructive Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Peak concentration of Troponin I

  From the randomization to the postoperative day 3 (POD 3)

Secondary Outcomes (12)

• The need for (yes/no) inotropic agents

  through study completion, an average of 4 weeks

• The need for (yes/no) defibrillation

  through study completion, an average of 4 weeks

• The incidence of new-onset moderate and severe arrhythmias of cardiac arrest

  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

Study Arms (2)

Esmolol

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Esmolol DRUG

Esmolol injected intravenously and added to cardioplegia solution

Esmolol

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Signed informed consent
• Patient with hypertrophic obstructive cardiomyopathy undergoing surgery under cardiopulmonary bypass

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

E. Meshalkin National Medical Research Center

Novosibirsk, Russia

RECRUITING

Related Links

• Related Info
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MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

esmolol

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Central Study Contacts

Vladimir Lomivorotov

CONTACT

+79139164103; vvlom@mail.ru

Alexander Bogachev-Prokophiev

CONTACT

bogachev.prokophiev@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: October 11, 2021
• Study Start: October 6, 2021
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: October 11, 2021

Record last verified: 2021-10

Locations

RU (1)