Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-28 @ 8:45 AM
Study NCT ID:
NCT05084495
Status:
COMPLETED
Last Update Posted:
2025-09-11
First Post:
2021-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Flecainide for Treatment of Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004562', 'term': 'Electrocardiography'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2021-10-18', 'studyFirstSubmitQcDate': '2021-10-18', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arrythmia free health status', 'timeFrame': 'During the 12 month follow up', 'description': 'Can we predict who will maintain a normal sinus rhythm prior to initiation of flecainide? treatment start'}], 'secondaryOutcomes': [{'measure': 'Number of AF-free months', 'timeFrame': 'During the 12 month follow up', 'description': 'Can we improve the number of AF-free months by a better prediction model'}, {'measure': 'Frequency of side effects', 'timeFrame': 'During the 12 month follow up', 'description': 'Can we improve the diagnostic accuracy to reduce the frequency of side effects'}, {'measure': 'Risk of pro-arrhythmias', 'timeFrame': 'During the 12 month follow up', 'description': 'Can we improve the diagnostic accuracy to reduce risk of pro-arrhythmias'}, {'measure': 'Mortality', 'timeFrame': 'During the 12 month follow up', 'description': 'Can we improve the diagnostic accuracy to reduce risk mortality'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '25717355', 'type': 'BACKGROUND', 'citation': 'Andrikopoulos GK, Pastromas S, Tzeis S. Flecainide: Current status and perspectives in arrhythmia management. World J Cardiol. 2015 Feb 26;7(2):76-85. doi: 10.4330/wjc.v7.i2.76.'}, {'pmid': '21138930', 'type': 'BACKGROUND', 'citation': 'Aliot E, Capucci A, Crijns HJ, Goette A, Tamargo J. Twenty-five years in the making: flecainide is safe and effective for the management of atrial fibrillation. Europace. 2011 Feb;13(2):161-73. doi: 10.1093/europace/euq382. Epub 2010 Dec 7.'}, {'pmid': '2473403', 'type': 'BACKGROUND', 'citation': 'Cardiac Arrhythmia Suppression Trial (CAST) Investigators. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. N Engl J Med. 1989 Aug 10;321(6):406-12. doi: 10.1056/NEJM198908103210629.'}, {'pmid': '2233383', 'type': 'BACKGROUND', 'citation': 'Macfarlane PW, Devine B, Latif S, McLaughlin S, Shoat DB, Watts MP. Methodology of ECG interpretation in the Glasgow program. Methods Inf Med. 1990 Sep;29(4):354-61.'}, {'pmid': '29848496', 'type': 'BACKGROUND', 'citation': 'Skov MW, Ghouse J, Kuhl JT, Platonov PG, Graff C, Fuchs A, Rasmussen PV, Pietersen A, Nordestgaard BG, Torp-Pedersen C, Hansen SM, Olesen MS, Haunso S, Kober L, Gerds TA, Kofoed KF, Svendsen JH, Holst AG, Nielsen JB. Risk Prediction of Atrial Fibrillation Based on Electrocardiographic Interatrial Block. J Am Heart Assoc. 2018 May 30;7(11):e008247. doi: 10.1161/JAHA.117.008247.'}, {'pmid': '20133512', 'type': 'BACKGROUND', 'citation': 'Kuppahally SS, Akoum N, Burgon NS, Badger TJ, Kholmovski EG, Vijayakumar S, Rao SN, Blauer J, Fish EN, Dibella EV, Macleod RS, McGann C, Litwin SE, Marrouche NF. Left atrial strain and strain rate in patients with paroxysmal and persistent atrial fibrillation: relationship to left atrial structural remodeling detected by delayed-enhancement MRI. Circ Cardiovasc Imaging. 2010 May;3(3):231-9. doi: 10.1161/CIRCIMAGING.109.865683. Epub 2010 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'This prospective observational study will include patients with atrial fibrillation that has indication for treatement with flecainide. Included patients are followed during a 12 month period. During the follow-up period they will have four clinical visits, during which clinical data, advanced echocardiographic data (strain and speckle tracking) and ECGs (Glasgow criteria) will be collected. These data will be analysed in relation to outcome parameters as: maintaining a normal sinus rhythm (arrythmia free health status), number of AF-free months, chances of successful electrical cardioversion, frequency of side effects, risk of pro-arrhythmias and mortality. The importance of these two analyses is to improve the use of flecainide. Hence, today patients with low benefit compared to risk of adverse events are inappropriately treated with flecainide with the "trial and error" approach currently used. On the other hand flecainide is currently underutilized, and patients denied the treatment that could improve their quality of life, prognosis and reduce their risk of cardiovascular adverse events. By investigating novel and promising parameters there is the potential of a better prediction of initiating safe and accurate anti-arrhythmic therapy for patients with atrial fibrillation.', 'detailedDescription': 'Study synopsis for the Tambocor Prospective study\n\nInclusion: Patients with atrial fibrillation that admitted to the ward for prior to start of flecainide initiation.\n\nEthics: Informed Concent prior to inclusion.\n\nFollow up after baseline: 4 visits during 12 month.\n\nEnd points : Side effects that lead to discontinuation of flecainide. Persistent AF that lead to discontinuation of flecainide.\n\nEvaluated parameters: 12 lead ECG, ECHO: LA, LV, HV strain , Dynamic Heart model: LV and RV.\n\nThe follow up visits:\n\nBaseline: Normal ECHO after the first dose of flecainide, ECG and Questionnaire\n\n4 Weeks: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire.\n\n6 month: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire.\n\n12 month: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'For patients with troublesome fibrillation burden, there are about as many ways to initiate and follow up treatment with Flecainide as there are Swedish hospitals. Although it was 30 years ago that the CAST study showed that Flecainide should not be given to patients with ischemic or structural heart disease, there is a lack of knowledge about which patient characteristics predict an effective and safe treatment. Today, the clinician is forced to use Flecainide according to the "trial-and-error" method, you simply have to see which patients benefit from the drug by trying. Regardless of the effect, patients are at risk of serious proarrhythmias and side effects.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with written informed consent who are eligible for flecainide treatment for atrial fibrillation.\n* The patients must be followed at the Skånes hospitals northwest and Skånes university hospitals.\n* Age \\>18 years\n\nExclusion Criteria:\n\n* Flecainide treatment with other indication than atrial fibrillation (including atrial flutter).\n* No secure date for treatment start.\n* Age \\<18 years'}, 'identificationModule': {'nctId': 'NCT05084495', 'briefTitle': 'The Use of Flecainide for Treatment of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Can Global Peak Longitudinal Strain Measurements in Combination With Non-invasive ECG Parameters Predict the Success or Failure of Flecainide Treatment for Atrial Fibrillation Patients?', 'orgStudyIdInfo': {'id': 'Tambocor_prosp_01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Global peak atrial longitudinal strain and ECG', 'type': 'DIAGNOSTIC_TEST', 'description': 'During the follow-up period the patient will have four clinical visits, during which clinical data, advanced echocardiographic data (strain and speckle tracking) and ECGs (Glasgow criteria) will be collected'}]}, 'contactsLocationsModule': {'locations': [{'zip': '25187', 'city': 'Helsingborg', 'state': 'Skåne County', 'country': 'Sweden', 'facility': 'Clinical Sciences, Helsingborg Medical Faculty Lund University', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}], 'overallOfficials': [{'name': 'Bjarne Madsen Härdig, RN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University and Region Skane'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}