National Cheng Kung University Hospital
Tainan, 704, Taiwan
Location status: Recruiting
NCT Number: NCT07799519
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.
This 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.
The investigators hypothesize that finerenone will lower AF recurrence after ablation, partly through modulation of EAT function.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 2
Tainan, 704, Taiwan
Location status: Recruiting
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/ epicardial adipose tissue remodeling and whether changes in UCP1 relate to outcomes after AF ablation.
All 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.
Finerenone dosing: 10 mg once daily if eGFR 25-<60 mL/min/1.73 m2; 20 mg once daily if eGFR >=60 mL/min/1.73 m2; up-titration at Week 4 where applicable if serum potassium <=4.8 mmol/L. Treatment duration: 12 months.
Follow-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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Karendia
Time frame: From day 91 (end of the 90-day blanking period) to 12 months after ablation
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.
Time frame: From day 91 to 12 months after ablation
Time from the end of the blanking period to the first documented atrial arrhythmia episode >=30 seconds.
Time frame: 3, 6, and 12 months
Percentage of time in atrial fibrillation on 24-hour Holter monitoring
Time frame: From day 91 to 12 months after ablation
Proportion of participants requiring antiarrhythmic drug therapy after the 90-day blanking period.
Time frame: Up to 12 months after ablation
Proportion of participants undergoing repeat catheter ablation or cardioversion for recurrent atrial arrhythmia.
Time frame: Up to 12 months after ablation
Number of participants with all-cause and cardiovascular hospitalization
Time frame: Up to 12 months after ablation
Incidence of adverse events, including hyperkalemia (serum potassium >5.5 mmol/L), hypotension, and worsening renal function
Time frame: Baseline to 12 months
Change in total EAT volume (cm3), defined as contiguous voxels with attenuation between -190 and -15 Hounsfield units within the pericardial contour.
Time frame: Baseline to 12 months
Change in EAT mean attenuation (HU)
Time frame: Baseline, 1 month, 6 months, and 12 months
Change in circulating UCP1 measured by ELISA, as a peripheral biomarker of adipose tissue browning.
Time frame: Baseline, 6 months, and 12 months
Change in peak atrial longitudinal strain (PALS) and peak atrial contractile strain (PACS) by two-dimensional speckle-tracking echocardiography.
Time frame: Baseline, 1 month, 6 months, and 12 months
Changes in NT-proBNP measured by clinical laboratory immunoassay
Time frame: Baseline, 6 months, and 12 months
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.
Time frame: Baseline, 1 month, 6 months, and 12 months
Changes in hsCRP measured by clinical laboratory immunoassay
Time frame: Baseline, 1 month, 6 months, and 12 months
Changes in TGF-beta measured by ELISA
Time frame: Baseline, 1 month, 6 months, and 12 months
Changes in PINP measured by ELISA
Time frame: Baseline, 1 month, 6 months, and 12 months
Changes in PIIINP measured by ELISA
Contact information is provided by the study sponsor or research team.
National Cheng-Kung University Hospital
Other
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
Acronym: FINE-CA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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