Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2026-01-01 @ 3:20 PM
Study NCT ID:
NCT06272357
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2023-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Antiarrhythmic Drugs in Pediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000889', 'term': 'Anti-Arrhythmia Agents'}], 'ancestors': [{'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2024-02-20', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detect the rate of use of antiarrhythmic drugs in pediatrics and the different indications for them other than the control of arrhythmia.', 'timeFrame': 'Baseline', 'description': "A study on the use of antiarrhythmic drugs in pediatric age group, in Assiut University Children's Hospital and the different indications for them other than the control of arrhythmia"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Antiarrhythmic Drug Adverse Reaction']}, 'descriptionModule': {'briefSummary': "A study on the use of antiarrhythmic drugs in pediatric age group, in Assiut University Children's Hospital, a clinical audit", 'detailedDescription': 'Arrhythmias occur in children and adolescents with congenital heart disease as well as those with structurally normal hearts.\n\nRhythm disturbances (arrhythmias) are not uncommon in sick children admitted in pediatric intensive care unit. These occur as a result of abnormalities in, or insults to, the cardiac conduction system or heart tissues. A rhythm disturbance in a child should be treated as life threatening emergency.\n\nThe generation of the action potential and the regional differences that are observed throughout the heart are the result of the selective permeability of ion channels distributed on the cell membrane.\n\nAbnormalities in surface membrane ion channel function are central to arrhythmogenesis.\n\nAntiarrhythmic medications primarily affect the ion channels in cardiac myocytes that are responsible for generating currents that create the action potential.\n\nBy altering the activity of these ion channels, the action potential is changed to reduce the likelihood of sustained arrhythmias.\n\nThese drugs are predominantly used in treatment of arrhythmia but in addition they are also used as a treatment of other cardiac and non-cardiac conditions.\n\nFor example, Calcium channel blockers have been one of the most widely used classes of antihypertensive agents in the last 20 years.\n\nCarvedilol (a beta blocker agent) can be safely used for treatment of chronic heart dysfunction in pediatric patients with dilated cardiomyopathy.\n\nβ-blockers are also an essential component of pharmacologic therapy for children with congestive heart failure.\n\nThere is a wide range of antiarrhythmic drugs used in treatment of arrhythmias. The modernized comprehensive classification of both established and potential antiarrhythmic drugs was proposed in 2018 Class 0: HCN channel-mediated pacemaker current (If) block Class I: Antiarrhythmic that affect sodium channels (slow depolarization) Class II: Drugs that counteract the sympathetic nervous system, predominantly beta-blockers Class III: drugs that affect the potassium channels (prolong repolarization) Class IV: Drugs that affect calcium channels (Calcium channel blockers) Class V: mechanically sensitive ion channels, Mechanosensitive channel blockers Class VI: Gap junction channel blockers Class VII: Upstream target modulators.\n\nIn this study the aim is to describe the use of Cardiovascular Drugs in Pediatric Cardiology unit Assiut University. As regard: indications of use, proper dosage and proper management of side effects of their use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '30 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Patients with Arrhythmic cardiac diseases admitted at cardiology unit Assiut University Hospital aged from 1 month to 18 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Patients with Arrhythmic cardiac diseases admitted at cardiology unit Assiut University Hospital aged from 1 month to 18 years.\n* All patient receiving antiarrhythmic drugs admitted to Assiut University Hospital for Children.\n\nExclusion Criteria:\n\n• Any patient on drugs other than antiarrhythmics.'}, 'identificationModule': {'nctId': 'NCT06272357', 'briefTitle': 'The Use of Antiarrhythmic Drugs in Pediatrics', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Clinical Audit on the Use of Antiarrhythmic Drugs in Pediatric Age Group', 'orgStudyIdInfo': {'id': 'Antiarrhythmic drugs'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Antiarrhythmic drugs', 'type': 'OTHER', 'description': 'Antiarrhythmic drugs in pediatrics'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Reham Abdel-Aziz Mohamed, Resident doctor', 'role': 'CONTACT', 'email': 'rema31997@gmail.com', 'phone': '+201098345222'}, {'name': 'Salah-Eldin Amry, professor', 'role': 'CONTACT', 'email': 'S_amry@yahoo.com', 'phone': '+201146082024'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Reham Abdel-Aziz mohamed', 'investigatorAffiliation': 'Assiut University'}}}}