Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-28 @ 8:35 AM
Study NCT ID:
NCT04588935
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2020-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017298', 'term': 'Bisoprolol'}, {'id': 'D020913', 'term': 'Perindopril'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2020-10-09', 'studyFirstSubmitQcDate': '2020-10-09', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'development of cardiovascular diseases and complications', 'timeFrame': '4 years', 'description': "hypertension, cardiomyopathy, arrhythmia's, myocardial infarction, heart failure"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Women With Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications', 'detailedDescription': 'Purpose of the study: to develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy.\n\nExclusion Criteria:\n\n* presence of other oncological diseases'}, 'identificationModule': {'nctId': 'NCT04588935', 'briefTitle': 'Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'State Institution "Republican Scientific and Practical Center" Cardiology, Belarus'}, 'officialTitle': 'To Develop and Implement a Method for Medical Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer', 'orgStudyIdInfo': {'id': '20192755'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group 1', 'description': 'women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, untreated'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, receiving treatment with a combination of bisoprolol and perindopril', 'interventionNames': ['Drug: Bisoprolol; Perindopril;']}], 'interventions': [{'name': 'Bisoprolol; Perindopril;', 'type': 'DRUG', 'otherNames': ['Bisoprolol; Perindopril'], 'description': 'based on the results of the patient study, different drug therapy regimens for cardiovascular complications during chemotherapy will be proposed', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220000', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'Scientific and Practice Center of Cardiology', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State Institution "Republican Scientific and Practical Center" Cardiology, Belarus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher, Hypertension Laboratory Republican Scientific and Clinical Cardiology Center Republic of Belarus, Belarus', 'investigatorFullName': 'Dr. Chernyak Sergey', 'investigatorAffiliation': 'State Institution "Republican Scientific and Practical Center" Cardiology, Belarus'}}}}