Finerenone After Catheter Ablation to Reduce Atrial Fibrillation Recurrence

NCT07799519 | Recruiting Phase 2

• 1 other identifier: NCKUH-11502012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation (AF)

Keywords

Finerenone; Catheter ablation; Epicardial adipose tissue; UCP1

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Time to first atrial fibrillation recurrence

  From day 91 to 12 months after ablation

• Atrial fibrillation burden

  3, 6, and 12 months

• Use of antiarrhythmic drugs after the blanking period

  From day 91 to 12 months after ablation

• Repeat ablation or cardioversion

  Up to 12 months after ablation

• Hospitalization

  Up to 12 months after ablation

Other Outcomes (6)

• Change in NT-proBNP by clinical laboratory immunoassay

  Baseline, 1 month, 6 months, and 12 months

• Change in epicardial adipose tissue (EAT) thickness measured by transthoracic echocardiography

  Baseline, 6 months, and 12 months

• Changes in hsCRP by clinical laboratory immunoassay

  Baseline, 1 month, 6 months, and 12 months

Study Arms (2)

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-\<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.

Drug: Finerenone

Usual care

NO INTERVENTION

Following successful pulmonary vein isolation, participants receive standard-of-care post-ablation management without finerenone.

Interventions

Finerenone 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.

Also known as: Karendia

Finerenone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

finerenone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chaoyu Chen

CONTACT

886-6-2353535; oripast@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: September 2, 2026
• Study Start: June 9, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)