[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589079":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":104,"collaborators":108,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":130,"minAge":131,"maxAge":10,"enrollmentInfo":132,"targetDuration":10,"studyType":135,"phases":10,"briefSummary":136,"conditions":137,"keywords":146,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"University of Athens","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"High PVC Burden Cohort",null,"Persistent, high PVC Burden (\\>5%) in 24h Holter Monitoring",[13],"Drug: Flecainide (monotherapy)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Flecainide (monotherapy)","• Medication: Flecainide acetate, administered orally.\n\n* Initial Dosing and Titration:\n* Patients were started on an appropriate dose based on body weight and renal function.\n* The typical starting dose was 100-150 mg per day, split into two doses.\n* Dosing was titrated as needed, depending on patient response and tolerability, under close ECG and clinical monitoring.\n* Monitoring Protocol:\n* Continuous ECG monitoring during drug initiation (especially in-hospital or via Holter).\n* Regular outpatient follow-up visits, including:\n* 12-lead ECGs\n* Holter monitoring\n* Echocardiography (to monitor LVEF and assess for reverse remodeling)\n* ECG parameters (QRS width, QTc interval) were closely monitored for proarrhythmic changes.",[9],[21],{"name":22,"affiliation":5,"role":23},"Dimitrios Tsiachris, MD, PhD","STUDY_CHAIR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","+306944849926","dtsiachris@yahoo.com",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Sotirios Kotoulas, MD, MBA","+306945012410","soter96@icloud.com",[34,48,66,80,90,99],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":10},"Cardiology Clinic, University Hospital of Patras","RECRUITING","Pátrai","Achaia","26504","Greece","GR",{"type":43,"coordinates":44},"Point",[45,46],21.73508,38.2462,{"lat":46,"lon":45},{"facility":49,"status":36,"city":50,"state":51,"zip":52,"country":40,"countryCode":41,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"1st Cardiology Clinic, National and Kapodistrian University of Athens","Athens","Attica","11527",{"type":43,"coordinates":54},[55,56],23.72784,37.98376,{"lat":56,"lon":55},[59,60,61,64],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},{"name":30,"role":26,"phone":10,"phoneExt":10,"email":10},{"name":62,"role":63,"phone":10,"phoneExt":10,"email":10},"Konstantinos P Tsioufis, MD, PhD","SUB_INVESTIGATOR",{"name":65,"role":63,"phone":10,"phoneExt":10,"email":10},"Athanas Kordalos, MD, PhD",{"facility":67,"status":36,"city":68,"state":10,"zip":69,"country":40,"countryCode":41,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Cardilogy Clinic, University of Crete","Heraklion","71500",{"type":43,"coordinates":71},[72,73],25.14341,35.32787,{"lat":73,"lon":72},[76],{"name":77,"role":26,"phone":78,"phoneExt":10,"email":79},"Eleftherios Kallergis, MD, PhD","+306941509898","eleftherioskallergis@gmail.com",{"facility":81,"status":82,"city":83,"state":10,"zip":84,"country":40,"countryCode":41,"cosmosGeoPoint":85,"geoPoint":89,"contacts":10},"2nd Cardiology Clinic, University of Ioannina","ACTIVE_NOT_RECRUITING","Ioannina","45110",{"type":43,"coordinates":86},[87,88],20.85187,39.66341,{"lat":88,"lon":87},{"facility":91,"status":82,"city":92,"state":10,"zip":93,"country":40,"countryCode":41,"cosmosGeoPoint":94,"geoPoint":98,"contacts":10},"2nd Cardiology Clinic, Aristotle University of Thessaloniki","Thessaloniki","54124",{"type":43,"coordinates":95},[96,97],22.93493,40.64072,{"lat":97,"lon":96},{"facility":100,"status":82,"city":92,"state":10,"zip":93,"country":40,"countryCode":41,"cosmosGeoPoint":101,"geoPoint":103,"contacts":10},"3rd Cardiology Clinic, Aristotle University of Thessaloniki",{"type":43,"coordinates":102},[96,97],{"lat":97,"lon":96},{"type":105,"investigatorFullName":106,"investigatorTitle":107,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Tsiachris Dimitrios","MD, PhD, Assistant Professor of Cardiology",[109,112,114,116,118],{"name":110,"class":111},"Institute for Study, Research, Education and Therapy of Vascular, Heart, Brain and Kidney Nosologies","UNKNOWN",{"name":113,"class":6},"University of Patras",{"name":115,"class":6},"University General Hospital of Heraklion",{"name":117,"class":6},"Aristotle University Of Thessaloniki",{"name":119,"class":120},"Uni-Pharma","INDUSTRY","100589079","flecainide-in-idiopathic-premature-ventricular-contractions-and-related-cardiomyopathy-100589079",false,"NCT06949748","Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy","UNIFLECA Study: Prospective Cohort Study on Flecainide's Impact on Persistent High Premature Ventricular Contraction Burden and PVC-Induced Cardiomyopathy","UNIFLECA","Inclusion Criteria:\n\n* Frequent idiopathic PVCs (burden \\>5% on multiple 24-hour Holter ECG recordings)\n* Normal cardiac structure and function on echocardiography\n* No late gadolinium enhancement or myocardial scar on cardiac MRI\n* Normal coronary angiography (excluding ischemic cardiomyopathy)\n* Normal serum electrolytes and renal function\n* Willingness to comply with follow-up schedule and drug titration\n\nExclusion Criteria:\n\n* Structural heart disease\n* Ischemic heart disease (confirmed by angiography)\n* History of sustained ventricular arrhythmias\n* Left ventricular ejection fraction (LVEF) \\\u003C40% at baseline\n* Brugada syndrome, long QT syndrome, or other channelopathies\n* Contraindications to class IC agents\n* Use of concurrent antiarrhythmics or proarrhythmic drugs",true,"ALL","18 Years",{"count":133,"type":134},300,"ESTIMATED","OBSERVATIONAL","The UNIFLECA study is a prospective, single-arm, observational cohort evaluating the efficacy, safety, and tolerability of flecainide (in the form of Sanocard) in adults with frequent idiopathic premature ventricular contractions (PVCs) and suspected PVC-induced cardiomyopathy (PVCi-CMP). Frequent PVCs-defined as a burden \\>5% on two separate 24-hour Holter recordings-are increasingly recognized as a cause of reversible systolic dysfunction in patients without structural heart disease.\n\nParticipants undergo a comprehensive baseline evaluation including echocardiography, occasionally cardiac MRI, and coronary angiography or equivalent testing to confirm the absence of structural abnormalities. Patients are enrolled only if they are ineligible or unwilling to undergo catheter ablation, and have no contraindications to flecainide.\n\nFlecainide therapy is initiated at a starting dose of 100 mg\u002Fday and titrated up to 200 mg\u002Fday, guided by ECG findings, symptom response, and QRS duration. Regular follow-up occurs at three-month intervals over three years, with periodic 24-hour Holter monitoring and assessment of symptoms, LVEF, and adverse events.\n\nThe primary outcome is the reduction in PVC burden. Secondary outcomes include improvement in LVEF, symptom relief (measured by structured questionnaires), adverse effects, and long-term treatment adherence. The study aims to generate real-world data on the non-invasive management of PVCs with flecainide and explore its role as an alternative to ablation in carefully selected patients.",[138,139,140,141,142,143,144,145],"Premature Ventricular Beats","Premature Ventricular Complexes","Premature Ventricular Contraction (PVC)","Arrhythmia Ventricular","Ventricular Dysfunction, Left","Ventricular Dysfunction","Cardiomyopathies, Secondary","Cardiomyopathies",[147,148,127,149,150,151,152,153],"Flecainide","Sanocard","PVC induced CMP","PVC","Premature Ventricular Contraction","Outflow Tract PVC","NonOutflow Tract PVC","2025-06-27",{"date":156,"type":157},"2025-07-02","ACTUAL",{"date":159,"type":157},"2024-04-26",{"date":161,"type":134},"2027-12-01",{"name":5,"class":6},6]