Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-27 @ 10:40 PM
Study NCT ID:
NCT04837261
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2021-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shortening Duration of Antiarrhythmic Medication for SVT in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013617', 'term': 'Tachycardia, Supraventricular'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011433', 'term': 'Propranolol'}, {'id': 'D005424', 'term': 'Flecainide'}, {'id': 'D000638', 'term': 'Amiodarone'}], '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': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2021-04-07', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of SVT after antiarrhythmic medication', 'timeFrame': '1 year follow-up'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with treatment failure', 'timeFrame': '4 months of antiarrhythmic medication'}, {'measure': 'Prevalence of adverse events', 'timeFrame': '4 months of antiarrhythmic medication'}, {'measure': 'Recurrence of SVT after one year follow-up', 'timeFrame': '5 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tachycardia, Supraventricular', 'Anti-Arrhythmia Agents', 'Arrhythmias, Cardiac'], 'conditions': ['Supraventricular Tachycardia']}, 'descriptionModule': {'briefSummary': 'The infants diagnosed with SVT are treated with antiarrhythmic medication to prevent the recurrence of SVT. This prospective observational cohort study evaluates efficacy and safety of shortening duration of antiarrhythmic medication to four months in infants with SVT. Primary outcome is incidence of recurrent SVT in infants after 4 months of antiarrhythmic medication compared to retrospectively reviewed cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Infants age less than 6 months with SVT due to AVRT or AVNRT', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 6 months or less\n* Documented SVT due to AVRT or AVNRT\n\nExclusion Criteria:\n\n* Age \\> 6 months\n* Ectopic atrial tachycardia\n* Atrial flutter\n* Atrial fibrillation\n* Permanent junctional reciprocating tachycardia'}, 'identificationModule': {'nctId': 'NCT04837261', 'briefTitle': 'Shortening Duration of Antiarrhythmic Medication for SVT in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Shortening Duration of Antiarrhythmic Medication for SVT in Infants', 'orgStudyIdInfo': {'id': 'R20113'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Propranolol', 'type': 'DRUG', 'description': '3 mg/kg/d, divided in four doses when age less than 3 months and in three doses when age more than 3 months'}, {'name': 'Flecainide', 'type': 'DRUG', 'description': '80 mg/m2/d'}, {'name': 'Amiodarone', 'type': 'DRUG', 'description': 'Single dose of 10 mg/kg/d 10-14 days, 5 mg/kg/d'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40620', 'city': 'Jyväskylä', 'state': 'Central Finland', 'country': 'Finland', 'facility': 'Central Finland Central Hospital', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'zip': '87300', 'city': 'Kajaani', 'state': 'Kainuu', 'country': 'Finland', 'facility': 'Kajaani Central Hospital', 'geoPoint': {'lat': 64.22728, 'lon': 27.72846}}, {'zip': '13530', 'city': 'Hämeenlinna', 'state': 'Kanta-Häme', 'country': 'Finland', 'facility': 'Hämeenlinna Central Hospital', 'geoPoint': {'lat': 60.99596, 'lon': 24.46434}}, {'zip': '67200', 'city': 'Kokkola', 'state': 'Keski-Pohjanmaa', 'country': 'Finland', 'facility': 'Kokkola Central Hopsital', 'geoPoint': {'lat': 63.83847, 'lon': 23.13066}}, {'zip': '96101', 'city': 'Rovaniemi', 'state': 'Lapland', 'country': 'Finland', 'facility': 'Lapland Central Hospital', 'geoPoint': {'lat': 66.49897, 'lon': 25.68867}}, {'zip': '90220', 'city': 'Oulu', 'state': 'North Ostrobothnia', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '70029', 'city': 'Kuopio', 'state': 'Northern Savonia', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '15850', 'city': 'Lahti', 'state': 'Paijat-Hame Region', 'country': 'Finland', 'facility': 'Lahti Central Hospital', 'geoPoint': {'lat': 60.98267, 'lon': 25.66151}}, {'zip': '33520', 'city': 'Tampere', 'state': 'Pirkanmaa', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '65130', 'city': 'Vaasa', 'state': 'Pohjanmaa', 'country': 'Finland', 'facility': 'Vaasa Central Hospital', 'geoPoint': {'lat': 63.096, 'lon': 21.61577}}, {'zip': '80210', 'city': 'Joensuu', 'state': 'Pohjois-Karjala', 'country': 'Finland', 'facility': 'North Karelia Central Hospital', 'geoPoint': {'lat': 62.60118, 'lon': 29.76316}}, {'zip': '48210', 'city': 'Kotka', 'state': 'Region of Kymenlaakso', 'country': 'Finland', 'facility': 'Kymenlaakso Central Hospital', 'geoPoint': {'lat': 60.4664, 'lon': 26.94582}}, {'zip': '28500', 'city': 'Pori', 'state': 'Satakunta', 'country': 'Finland', 'facility': 'Sakunta Central Hospital', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}, {'zip': '53130', 'city': 'Lappeenranta', 'state': 'South Karelia Region', 'country': 'Finland', 'facility': 'South Karelia Central Hospital', 'geoPoint': {'lat': 61.05871, 'lon': 28.18871}}, {'zip': '60220', 'city': 'Seinäjoki', 'state': 'South Ostrobothnia', 'country': 'Finland', 'facility': 'Seinäjoki Central Hospital', 'geoPoint': {'lat': 62.79446, 'lon': 22.82822}}, {'zip': '50100', 'city': 'Mikkeli', 'state': 'South Savo', 'country': 'Finland', 'facility': 'Mikkeli Central Hospital', 'geoPoint': {'lat': 61.68857, 'lon': 27.27227}}, {'zip': '20521', 'city': 'Turku', 'state': 'Southwest', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '00029', 'city': 'Helsinki', 'state': 'Uusimaa', 'country': 'Finland', 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Tuija Poutanen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, {'name': 'Oulu University Hospital', 'class': 'OTHER'}, {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}