Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-30 @ 11:49 AM
Study NCT ID:
NCT06853951
Status:
RECRUITING
Last Update Posted:
2025-03-03
First Post:
2025-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardioprotection on Chemotherapy-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': 'D000806', 'term': 'Angiotensin-Converting Enzyme Inhibitors'}, {'id': 'D002216', 'term': 'Captopril'}, {'id': 'D000077261', 'term': 'Carvedilol'}], 'ancestors': [{'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D011392', 'term': 'Proline'}, {'id': 'D007098', 'term': 'Imino Acids'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Arm 1 Patients will receive ACEIs oral tablets during Induction Phase by either a caregiver or caring nurse.\n\nArm 2 Patients will receive β-blockers oral tablets during Induction Phase by either a caregiver or caring nurse.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-07-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': 'LVEF will be measured at Baseline and at the end of Induction Phase (42 Days)', 'description': 'he LVEF will be measure by 2D Echocardiography at baseline and at the end of Induction Phase (42 Days)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiotoxicity']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate the protective impact of cardioprotective medications on the chemotherapy- induced cardiotoxicity.', 'detailedDescription': 'The goal of this interventional study is to evaluate the protective impact of Angiotensin-converting enzyme (ACE) inhibitors versus β-blockers on the cardiotoxicity profile of pediatric patients with acute leukemia. The impact is measured by evaluation of left ventricular ejection fraction (LVEF) by 2D echocardiography at baseline and at the end of Induction phase (42 days).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willingness of the legal representative of research participant to participate in the study by giving "informed consent."\n* Ability to take oral medication.\n* Age 2-18 years at the time of diagnosis.\n\nExclusion Criteria:\n\n* Documented allergy to cardioprotective medications'}, 'identificationModule': {'nctId': 'NCT06853951', 'briefTitle': 'Cardioprotection on Chemotherapy-Induced Cardiotoxicity', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Effect of Cardioprotective Medications on Chemotherapy-Induced Cardiotoxicity in Childhood Acute Leukemia', 'orgStudyIdInfo': {'id': '315'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ACEIs', 'description': '0.3 mg/kg/dose every 8 hours orally by either a caregiver or caring nurse.', 'interventionNames': ['Drug: ACE Inhibitors']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'β-blockers', 'description': '0.05 mg/kg/dose every 12 hours orally by either a caregiver or caring nurse', 'interventionNames': ['Drug: β -Blockers']}], 'interventions': [{'name': 'ACE Inhibitors', 'type': 'DRUG', 'otherNames': ['Captopril'], 'description': '0.3 mg/kg/dose every 8 hours orally by either a caregiver or caring nurse.', 'armGroupLabels': ['ACEIs']}, {'name': 'β -Blockers', 'type': 'DRUG', 'otherNames': ['Carvedilol'], 'description': '0.05 mg/kg/dose every 12 hours orally by either a caregiver or caring nurse.', 'armGroupLabels': ['β-blockers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Aml Elkhouly, Assoc. Prof', 'role': 'CONTACT', 'email': 'Amal.Elkhouly@pharma.asu.edu.eg', 'phone': '0201060355448'}], 'facility': 'Faculty of Pharmacy, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Faculty of Pharmacy, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Christen Said', 'role': 'CONTACT', 'email': 'keristin.nazir21@pharma.asu.edu.eg', 'phone': '+201093942389'}], 'overallOfficials': [{'name': 'Manal Hamed El-Hamamsy, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant', 'investigatorFullName': 'keristin nazir', 'investigatorAffiliation': 'Ain Shams University'}}}}