About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80 years
Atrial fibrillation scheduled for first-time catheter ablation (pulmonary vein isolation)
Estimated glomerular filtration rate (eGFR) >=25 mL/min/1.73 m2
Serum potassium <=5.0 mmol/L
Disqualifiers
History of prior catheter-based or surgical pulmonary vein isolation
Current use of other mineralocorticoid receptor antagonists (MRAs)
Severe renal impairment (eGFR <25 mL/min/1.73 m2)
Serum potassium >5.0 mmol/L
Trial design
Parallel
Treatments tested in this trial
Finerenone
DrugOral 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Time to first atrial fibrillation recurrence
Time from the end of the blanking period to the first documented atrial arrhythmia episode \>=30 seconds.
Atrial fibrillation burden
Percentage of time in atrial fibrillation on 24-hour Holter monitoring
Use of antiarrhythmic drugs after the blanking period
Proportion of participants requiring antiarrhythmic drug therapy after the 90-day blanking period.
Repeat ablation or cardioversion
Proportion of participants undergoing repeat catheter ablation or cardioversion for recurrent atrial arrhythmia.
Other outcomes
Change in NT-proBNP by clinical laboratory immunoassay
Changes in NT-proBNP measured by clinical laboratory immunoassay
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.
Changes in hsCRP by clinical laboratory immunoassay
Changes in hsCRP measured by clinical laboratory immunoassay
Changes in TGF-beta by ELISA
Changes in TGF-beta measured by ELISA
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