Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT05792293
Status:
UNKNOWN
Last Update Posted:
2023-04-06
First Post:
2023-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D066126', 'term': 'Cardiotoxicity'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single blind'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-04', 'studyFirstSubmitDate': '2023-03-19', 'studyFirstSubmitQcDate': '2023-03-19', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of cancer therapy related cardiac dysfunction among the two groups', 'timeFrame': 'Six months', 'description': 'cancer therapy related cardiac dysfunction defined as drop in ejection fraction more than 10% and to a value below 53% assessed by 3D echocardiography'}], 'secondaryOutcomes': [{'measure': 'Changes in left ventricular ejection fraction assessed by 3D echocardiography among the two groups', 'timeFrame': 'Six months'}, {'measure': 'Changes in left ventricular volumes assessed by 3D echocardiography among the two groups', 'timeFrame': 'Six months'}, {'measure': 'Changes in left ventricular diastolic function among the two groups', 'timeFrame': 'Six months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anthracyclines', 'Doxorubuicn', 'Cardiotoxicity'], 'conditions': ['Doxorubicin Induced Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'This study aims at evaluating the role of Atorvastatin in prevention of Anthracycline induced cardiotoxicity', 'detailedDescription': 'The study participants are female patients with breast cancer receiving Anthracycline based chemotherapy.\n\nThey will be divided into 2 groups , the first group will receive 40 mg oral atorvastatin through out the study , while the other group will receive a placebo.\n\nFull echocardiographic study including 3D echocardiography will be done to all patients before starting their chemotherapy and after 6 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female patients diagnosed with breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients diagnosed with histology proven breast cancer with an indication to primary systemic therapy or adjuvant regimens based on anthracyclines\n\nExclusion Criteria:\n\n* Patients with impaired LV systolic function (EF below 50%)\n* Patients with severe valvular heart disease\n* Patients previously diagnosed with coronary artery disease\n* Patients with baseline elevated liver enzymes\n* Patients with prior chemotherapy or radiation therapy\n* Pregnant females'}, 'identificationModule': {'nctId': 'NCT05792293', 'briefTitle': 'Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity', 'orgStudyIdInfo': {'id': 'FMASUMD45/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy', 'interventionNames': ['Drug: Atorvastatin 40 Mg Oral Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Atorvastatin 40 Mg Oral Tablet', 'type': 'DRUG', 'description': '40 mg oral dose of atorvastatin , lipid lowering drug with other pleotropic effects', 'armGroupLabels': ['Study Group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed L Mohamed, Master', 'role': 'CONTACT', 'email': 'Doc.ahmedlotfy91@gmail.com', 'phone': '+201141141677'}], 'facility': 'Ain Shams University hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed L Mohamed, Master', 'role': 'CONTACT', 'email': 'Doc.ahmedlotfy91@gmail.com', 'phone': '+201141141677'}], 'overallOfficials': [{'name': 'Ahmed L Mohamed, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmed Lotfy Mohamed', 'investigatorAffiliation': 'Ain Shams University'}}}}