Finerenone After Catheter Ablation to Reduce Atrial Fibrillation Recurrence
Recruiting · NCT07799519 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
- Severe liver disease (Child-Pugh class C)
- Known hypersensitivity to the investigational drug
- Contraindications to the investigational drug, such as concomitant use of strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital)
- Active cancer or recent chemotherapy
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period
Where it is running
1 location listed.
- National Cheng Kung University Hospital - Tainan, Taiwan