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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Taiwan
National Cheng Kung University Hospital
RECRUITING
Tainan
Contact Information
Primary
Chaoyu Chen
oripast@gmail.com
886-6-2353535
Time Frame
Start Date: 2026-06-09
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 40
Treatments
Experimental: Finerenone
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-\<60 mL/min/1.73 m2, 20 mg QD if eGFR \>=60 mL/min/1.73 m2; up-titration to 20 mg QD at Week 4 where applicable if serum potassium \<=4.8 mmol/L.
No_intervention: Usual care
Following successful pulmonary vein isolation, participants receive standard-of-care post-ablation management without finerenone.
Sponsors
Leads: National Cheng-Kung University Hospital

This content was sourced from clinicaltrials.gov