Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 7:33 PM
Study NCT ID:
NCT05073094
Status:
UNKNOWN
Last Update Posted:
2021-10-11
First Post:
2021-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C036604', 'term': 'esmolol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-06', 'studyFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2021-10-06', 'lastUpdatePostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak concentration of Troponin I', 'timeFrame': 'From the randomization to the postoperative day 3 (POD 3)'}], 'secondaryOutcomes': [{'measure': 'The need for (yes/no) inotropic agents', 'timeFrame': 'through study completion, an average of 4 weeks', 'description': 'Number of patients requiring inotropic support'}, {'measure': 'The need for (yes/no) defibrillation', 'timeFrame': 'through study completion, an average of 4 weeks', 'description': 'Number of patients requiring defibrlillation after removal of aortic cross clamp'}, {'measure': 'The incidence of new-onset moderate and severe arrhythmias of cardiac arrest', 'timeFrame': 'through study completion, an average of 4 weeks', 'description': 'Number of patients with arrhythmias'}, {'measure': 'Left ventricular ejection fraction', 'timeFrame': 'through study completion, an average of 4 weeks'}, {'measure': 'Peak serum creatinine concentration', 'timeFrame': 'through study completion, an average of 4 weeks'}, {'measure': 'The incidence of acute kidney injury', 'timeFrame': 'through study completion, an average of 4 weeks'}, {'measure': 'Duration of mechanical ventilation', 'timeFrame': 'through study completion, an average of 4 weeks'}, {'measure': 'Duration of ICU stay', 'timeFrame': 'through study completion, an average of 4 weeks'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'through study completion, an average of 4 weeks'}, {'measure': '30-day all-cause mortality', 'timeFrame': 'through study completion, an average of 4 weeks'}, {'measure': 'Presence of diastolic dysfunction', 'timeFrame': 'through study completion, an average of 4 weeks'}, {'measure': 'The dosage of inotropic agents (inotropic score)', 'timeFrame': 'through study completion, an average of 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertrophic Obstructive Cardiomyopathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/33451954/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/27932571/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/29398384/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Signed informed consent\n* Patient with hypertrophic obstructive cardiomyopathy undergoing surgery under cardiopulmonary bypass\n\nExclusion Criteria:\n\n* History of adverse effects on esmolol\n* Urgent/emergent surgery\n* Administration of esmolol in 30 days before randomization\n* Participation in other randomized trial during same hospitalization'}, 'identificationModule': {'nctId': 'NCT05073094', 'briefTitle': 'Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Myocardial Protection With Esmolol in Patients With Hypertrophic Obstructive Cardiomyopathy Undergoing Surgery Under Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'BETABLOCK-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Esmolol', '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', 'interventionNames': ['Drug: Esmolol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Equivalent volume of saline as a bolus before aortic cross-clamping and in the cardioplegic solution', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Esmolol', 'type': 'DRUG', 'description': 'Esmolol injected intravenously and added to cardioplegia solution', 'armGroupLabels': ['Esmolol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Equivalent volume of placebo (saline) as a bolus before aortic cross-clamping and in the cardioplegic solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Novosibirsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Vladimir Lomivorotov, MD', 'role': 'CONTACT', 'email': 'vvlom@mail.ru'}], 'facility': 'E. Meshalkin National Medical Research Center', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'centralContacts': [{'name': 'Vladimir Lomivorotov', 'role': 'CONTACT', 'email': 'vvlom@mail.ru', 'phone': '+79139164103'}, {'name': 'Alexander Bogachev-Prokophiev', 'role': 'CONTACT', 'email': 'bogachev.prokophiev@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}