[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654376":3},{"organization":4,"outcomesModule":7,"designInfo":69,"detailedDescription":78,"studyPopulation":72,"armGroups":79,"interventions":90,"overallOfficials":72,"centralContacts":97,"locations":103,"responsibleParty":119,"collaborators":72,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":123,"sex":129,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":72,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":106,"whyStopped":72,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"National Cheng-Kung University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"Atrial fibrillation recurrence after the blanking period","Proportion of participants with any documented atrial arrhythmia episode (AF, atrial flutter, or atrial tachycardia) lasting \\>=30 seconds, detected by 24-hour Holter monitoring, 12-lead ECG, or symptom-triggered monitoring, occurring after the 90-day blanking period.","From day 91 (end of the 90-day blanking period) to 12 months after ablation",[14,18,22,25,29,32,35,39,42,46],{"measure":15,"description":16,"timeFrame":17},"Time to first atrial fibrillation recurrence","Time from the end of the blanking period to the first documented atrial arrhythmia episode \\>=30 seconds.","From day 91 to 12 months after ablation",{"measure":19,"description":20,"timeFrame":21},"Atrial fibrillation burden","Percentage of time in atrial fibrillation on 24-hour Holter monitoring","3, 6, and 12 months",{"measure":23,"description":24,"timeFrame":17},"Use of antiarrhythmic drugs after the blanking period","Proportion of participants requiring antiarrhythmic drug therapy after the 90-day blanking period.",{"measure":26,"description":27,"timeFrame":28},"Repeat ablation or cardioversion","Proportion of participants undergoing repeat catheter ablation or cardioversion for recurrent atrial arrhythmia.","Up to 12 months after ablation",{"measure":30,"description":31,"timeFrame":28},"Hospitalization","Number of participants with all-cause and cardiovascular hospitalization",{"measure":33,"description":34,"timeFrame":28},"Safety: incidence of adverse events","Incidence of adverse events, including hyperkalemia (serum potassium \\>5.5 mmol\u002FL), hypotension, and worsening renal function",{"measure":36,"description":37,"timeFrame":38},"Change in epicardial adipose tissue volume on cardiac CT","Change in total EAT volume (cm3), defined as contiguous voxels with attenuation between -190 and -15 Hounsfield units within the pericardial contour.","Baseline to 12 months",{"measure":40,"description":41,"timeFrame":38},"Change in epicardial adipose tissue mean attenuation on cardiac CT","Change in EAT mean attenuation (HU)",{"measure":43,"description":44,"timeFrame":45},"Change in serum uncoupling protein-1 (UCP1) concentration by ELISA","Change in circulating UCP1 measured by ELISA, as a peripheral biomarker of adipose tissue browning.","Baseline, 1 month, 6 months, and 12 months",{"measure":47,"description":48,"timeFrame":49},"Change in left atrial strain parameters by two-dimensional speckle-tracking echocardiography","Change in peak atrial longitudinal strain (PALS) and peak atrial contractile strain (PACS) by two-dimensional speckle-tracking echocardiography.","Baseline, 6 months, and 12 months",[51,54,57,60,63,66],{"measure":52,"description":53,"timeFrame":45},"Change in NT-proBNP by clinical laboratory immunoassay","Changes in NT-proBNP measured by clinical laboratory immunoassay",{"measure":55,"description":56,"timeFrame":49},"Change in epicardial adipose tissue (EAT) thickness measured by transthoracic echocardiography","Change in maximum epicardial adipose tissue thickness (in millimeters), measured by two-dimensional transthoracic echocardiography in the parasternal long-axis view, perpendicular to the right ventricular free wall at end-systole, averaged over three consecutive cardiac cycles.",{"measure":58,"description":59,"timeFrame":45},"Changes in hsCRP by clinical laboratory immunoassay","Changes in hsCRP measured by clinical laboratory immunoassay",{"measure":61,"description":62,"timeFrame":45},"Changes in TGF-beta by ELISA","Changes in TGF-beta measured by ELISA",{"measure":64,"description":65,"timeFrame":45},"Changes in PINP by ELISA","Changes in PINP measured by ELISA",{"measure":67,"description":68,"timeFrame":45},"Changes in PIIINP by ELISA","Changes in PIIINP measured by ELISA",{"allocation":70,"interventionModel":71,"interventionModelDescription":72,"primaryPurpose":73,"observationalModel":72,"timePerspective":72,"maskingInfo":74},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":75,"maskingDescription":72,"whoMasked":76},"SINGLE",[77],"OUTCOMES_ASSESSOR","This is a concept-generating study comprising three components: (1) a randomized controlled trial testing whether adjunctive finerenone after catheter ablation reduces AF recurrence compared with usual care; (2) cardiac CT to characterize the EAT phenotype before and after finerenone treatment; and (3) evaluation of whether serum UCP1 levels track brown\u002F epicardial adipose tissue remodeling and whether changes in UCP1 relate to outcomes after AF ablation.\n\nAll participants will undergo AF ablation with radiofrequency or pulsed field ablation for pulmonary vein isolation (wide antral circumferential ablation recommended). In persistent AF, posterior wall isolation may be added at the physician's discretion. After confirmation of entrance and exit block, participants will be randomized 1:1 (computer-generated sequence, stratified by left atrial diameter and AF type \\[paroxysmal vs nonparoxysmal\\]) to finerenone or usual care.\n\nFinerenone dosing: 10 mg once daily if eGFR 25-\\\u003C60 mL\u002Fmin\u002F1.73 m2; 20 mg once daily if eGFR \\>=60 mL\u002Fmin\u002F1.73 m2; up-titration at Week 4 where applicable if serum potassium \\\u003C=4.8 mmol\u002FL. Treatment duration: 12 months.\n\nFollow-up visits occur at 2 weeks, 1, 3, 6, 9, and 12 months. Antiarrhythmic drugs are permitted during the 90-day blanking period with discontinuation encouraged thereafter. Rhythm monitoring includes 24-hour Holter at baseline, 3, 6, and 12 months, and additional monitoring for symptoms. Transthoracic echocardiography (including left atrial strain and EAT thickness) is performed at baseline, 6, and 12 months; cardiac CT (EAT volume, mean attenuation, and density dispersion) at baseline and 12 months. Blood biomarkers (UCP1, NT-proBNP, hsCRP, TGF-beta, PINP, PIIINP) are measured at baseline, 1, 6, and 12 months.",[80,86],{"label":81,"type":82,"description":83,"interventionNames":84},"Finerenone","EXPERIMENTAL","Following successful pulmonary vein isolation, participants receive finerenone once daily for 12 months in addition to standard post-ablation care. Starting dose: 10 mg QD if eGFR 25-\\\u003C60 mL\u002Fmin\u002F1.73 m2, 20 mg QD if eGFR \\>=60 mL\u002Fmin\u002F1.73 m2; up-titration to 20 mg QD at Week 4 where applicable if serum potassium \\\u003C=4.8 mmol\u002FL.",[85],"Drug: Finerenone",{"label":87,"type":88,"description":89,"interventionNames":72},"Usual care","NO_INTERVENTION","Following successful pulmonary vein isolation, participants receive standard-of-care post-ablation management without finerenone.",[91],{"type":92,"name":81,"description":93,"armGroupLabels":94,"otherNames":95},"DRUG","Oral finerenone 10 mg or 20 mg once daily (dose per eGFR, with Week-4 up-titration where applicable based on serum potassium) for 12 months after catheter ablation.",[81],[96],"Karendia",[98],{"name":99,"role":100,"phone":101,"phoneExt":72,"email":102},"Chaoyu Chen","CONTACT","886-6-2353535","oripast@gmail.com",[104],{"facility":105,"status":106,"city":107,"state":72,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":117},"National Cheng Kung University Hospital","RECRUITING","Tainan","704","Taiwan","TW",{"type":112,"coordinates":113},"Point",[114,115],120.21333,22.99083,{"lat":115,"lon":114},[118],{"name":99,"role":100,"phone":101,"phoneExt":72,"email":102},{"type":120,"investigatorFullName":72,"investigatorTitle":72,"investigatorAffiliation":72,"oldNameTitle":72,"oldOrganization":72},"SPONSOR","100654376","phase-2-finerenone-after-catheter-ablation-to-reduce-atrial-fibrillation-recurrence-100654376",false,"NCT07799519","Finerenone After Catheter Ablation to Reduce Atrial Fibrillation Recurrence","Finerenone for Reducing Atrial Fibrillation Recurrence After Pulmonary Vein Isolation: A Randomized Pilot Trial With Mechanistic Assessment of Epicardial Adipose Tissue Remodeling and Brown Adipose Tissue Activation","FINE-CA","Inclusion Criteria:\n\n* Age 18-80 years\n* Atrial fibrillation scheduled for first-time catheter ablation (pulmonary vein isolation)\n* Estimated glomerular filtration rate (eGFR) \\>=25 mL\u002Fmin\u002F1.73 m2\n* Serum potassium \\\u003C=5.0 mmol\u002FL\n\nExclusion Criteria:\n\n* History of prior catheter-based or surgical pulmonary vein isolation\n* Current use of other mineralocorticoid receptor antagonists (MRAs)\n* Severe renal impairment (eGFR \\\u003C25 mL\u002Fmin\u002F1.73 m2)\n* Serum potassium \\>5.0 mmol\u002FL\n* Severe liver disease (Child-Pugh class C)\n* Known hypersensitivity to the investigational drug\n* Contraindications to the investigational drug, such as concomitant use of strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital)\n* Active cancer or recent chemotherapy\n* Women who are pregnant, breastfeeding, or planning to become pregnant during the study period","ALL","18 Years","80 Years",{"count":133,"type":134},40,"ESTIMATED","INTERVENTIONAL",[137],"PHASE2","Atrial fibrillation (AF) is a common heart rhythm disorder associated with stroke, heart failure, and increased mortality. Catheter ablation with pulmonary vein isolation (PVI) is an effective rhythm-control strategy, but 20-30% of patients experience AF recurrence within one year. Finerenone, a nonsteroidal mineralocorticoid receptor antagonist with anti-inflammatory, antifibrotic, and metabolic effects, was associated with a lower incidence of AF in prior large trials, and preclinical studies suggest it promotes \"browning\" of adipose tissue and improves epicardial adipose tissue (EAT) characteristics.\n\nThis single-center, randomized, investigator-blinded pilot trial will enroll 40 patients undergoing first-time catheter ablation for AF. After successful PVI, participants will be randomized 1:1 to receive finerenone or usual care for 12 months. The primary endpoint is AF recurrence (any atrial arrhythmia episode lasting 30 seconds or longer) after a 90-day blanking period, within 12 months post-ablation. Mechanistic endpoints include EAT remodeling assessed by cardiac computed tomography and echocardiography, and circulating uncoupling protein-1 (UCP1) levels as a biomarker of adipose tissue browning.\n\nThe investigators hypothesize that finerenone will lower AF recurrence after ablation, partly through modulation of EAT function.",[140],"Atrial Fibrillation (AF)",[81,142,143,144],"Catheter ablation","Epicardial adipose tissue","UCP1","2026-08-27",{"date":147,"type":148},"2026-09-02","ACTUAL",{"date":150,"type":148},"2026-06-09",{"date":152,"type":134},"2028-08-31",{"name":5,"class":6},1]