[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565674":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":72,"collaborators":74,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":25,"enrollmentInfo":90,"targetDuration":25,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":104,"whyStopped":25,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Institut Investigacio Sanitaria Pere Virgili","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Amiodarone orally impregnation starting one month before ECV","EXPERIMENTAL","Treatment impregnation with amiodarone starting one month before ECV (600 mg\u002Fday 1st week, 400 mg\u002Fday 2nd week and 200 mg\u002Fday thereafter until ECV).",[13],"Drug: Amiodarone (Antiarrhythmic drug)",{"label":15,"type":16,"description":17,"interventionNames":18},"Amiodarone orally impregnation started 5 days before ECV","ACTIVE_COMPARATOR","Treatment impregnation with amiodarone 800 mg\u002Fday started 5 days before ECV.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Amiodarone (Antiarrhythmic drug)","Comparing 2 regimes of amiodarone pre-electrical cardioversion witn ECG monitoring",[15,9],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Josep M. Alegret, MD, PhD","CONTACT","+34 689952316","josepmaria.alegret@urv.cat",[33,45,54,63],{"facility":34,"status":25,"city":35,"state":25,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":25},"Hospital Universitari Germans Trias i Pujol","Badalona","08916","Spain","ES",{"type":40,"coordinates":41},"Point",[42,43],2.24741,41.45004,{"lat":43,"lon":42},{"facility":46,"status":25,"city":47,"state":25,"zip":48,"country":37,"countryCode":38,"cosmosGeoPoint":49,"geoPoint":53,"contacts":25},"Hospital de la Santa Creu i Sant Pau","Barcelona","08025",{"type":40,"coordinates":50},[51,52],2.15899,41.38879,{"lat":52,"lon":51},{"facility":55,"status":25,"city":56,"state":25,"zip":57,"country":37,"countryCode":38,"cosmosGeoPoint":58,"geoPoint":62,"contacts":25},"Hospital Universitari de Sant Joan","Reus","43204",{"type":40,"coordinates":59},[60,61],1.10687,41.15612,{"lat":61,"lon":60},{"facility":64,"status":25,"city":65,"state":25,"zip":66,"country":37,"countryCode":38,"cosmosGeoPoint":67,"geoPoint":71,"contacts":25},"Hospital Clínico Universitario de Santiago","Santiago de Compostela","15706",{"type":40,"coordinates":68},[69,70],-8.54569,42.88052,{"lat":70,"lon":69},{"type":73,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[75,77],{"name":76,"class":6},"Spanish Society of Cardiology",{"name":78,"class":79},"Sociedad Espanola de Cardiologia","UNKNOWN","100565674","phase-4-evaluation-of-cardioverter-capacity-of-amiodarone-pre-electrical-cardioversion-in-persistent-atrial-fibrillation-100565674",false,"NCT06645249","Evaluation of Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation","Multicenter, Randomized Clinical Trial to Evaluate the Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation","PERIVERSION","Inclusion Criteria:\n\n1. Patients ≥18 years old.\n2. Persistent atrial fibrillation (≥ 7 days duration).\n3. Referred for elective electrical cardioversion.\n4. Signing of the informed consent\n\nExclusion Criteria:\n\n1. Need of urgent electrical cardioversion\n2. Mean Heart rate \\<50 bpm\n3. Planned ablation \\< 1 month after ECV.\n4. Treatment with anti-arrhythmic drugs (IC, III) the last 7 days previous to inclusion (in the case of amiodarone on the 30 days previous to inclusion)\n5. Atrial fibrillation post-cardiac surgery\n6. New York Heart Association (NYHA) Class IV heart failure\n7. Left ventricular ejection fraction (LVEF) ≤30%\n8. History of thyroid disease (hyperthyroidism or hypothyroidism)\n9. Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT\u002FAST \\> 3 x upper limit of normal (ULN)\n10. Allergy, intolerance, or known hypersensitivity to study medication\n11. Women of childbearing potential unwilling to use contraceptive measures\n12. Participation in another clinical trial involving investigational drugs\n13. Life expectancy less than 12 months\n14. Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction.","ALL","18 Years",{"count":91,"type":92},122,"ESTIMATED","INTERVENTIONAL",[95],"PHASE4","Phase: IV Population: Sample size= 122 patients; male and female; ≥ 18 y.o.; patients with persistent atrial fibrillation referred for electrical cardioversion; performed in Spain Number of Sites: 4 Study Duration: 15\u002F10\u002F2024 - 15\u002F5\u002F2026 Subject Participation Duration: 2-4 months (depending on the arm) Description of Agent or Intervention: amiodarone\n\nObjectives:\n\nPrimary: To compare the efficacy of amiodarone in pre-ECV reversal to sinus rhythm in a one-month impregnation regimen versus a 5-day regimen Secondary: 1) Identify days from initiation of pre-ECV amiodarone to reversion to SR using a mobile device paired to the mobile phone; 2) To compare the joint efficacy in the reversion to SR pre-ECV and in the maintenance of SR at 1 month after ECV of a one-month pre-ECV amiodarone impregnation regimen vs a 5-day regimen\n\nDescription of Study Design: Multicenter randomized open clinical trial. 122 Patients with persistent AF (≥7 days duration) electively referred for CVE will be included. Two amiodarone regimens administered pre-CVE will be compared evaluating their cardioverter efficacy. Patients will be randomized to 2 groups:\n\n1. Treatment impregnation with amiodarone starting one month before ECV (600 mg\u002Fday 1st week, 400 mg\u002Fday 2nd week and 200 mg\u002Fday thereafter until ECV).\n2. Treatment impregnation with amiodarone 800 mg\u002Fday started 5 days before ECV. Estimated Time to Complete Enrollment: 13 months",[98],"Atrial Fibrillation (AF)",[100,101,102,103],"Atrial fibrillation","Electrical cardioversion","amiodarone","Pharmacological cardioversion","NOT_YET_RECRUITING","2024-11-27",{"date":107,"type":108},"2024-12-02","ACTUAL",{"date":110,"type":92},"2024-12-10",{"date":112,"type":92},"2026-10",{"name":5,"class":6},4]