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Finerenone After Catheter Ablation to Reduce Atrial Fibrillation Recurrence

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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07799519
Acronym
FINE-CA
Enrollment
40
Registered
2026-09-02
Start date
2026-06-09
Completion date
2028-08-31
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF)

Keywords

Finerenone, Catheter ablation, Epicardial adipose tissue, UCP1

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.

Detailed description

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.

Interventions

DRUGFinerenone

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.

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Atrial fibrillation recurrence after the blanking periodFrom day 91 (end of the 90-day blanking period) to 12 months after ablationProportion 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

MeasureTime frameDescription
Safety: incidence of adverse eventsUp to 12 months after ablationIncidence of adverse events, including hyperkalemia (serum potassium \>5.5 mmol/L), hypotension, and worsening renal function
Change in epicardial adipose tissue volume on cardiac CTBaseline to 12 monthsChange in total EAT volume (cm3), defined as contiguous voxels with attenuation between -190 and -15 Hounsfield units within the pericardial contour.
Change in epicardial adipose tissue mean attenuation on cardiac CTBaseline to 12 monthsChange in EAT mean attenuation (HU)
Change in serum uncoupling protein-1 (UCP1) concentration by ELISABaseline, 1 month, 6 months, and 12 monthsChange in circulating UCP1 measured by ELISA, as a peripheral biomarker of adipose tissue browning.
Change in left atrial strain parameters by two-dimensional speckle-tracking echocardiographyBaseline, 6 months, and 12 monthsChange in peak atrial longitudinal strain (PALS) and peak atrial contractile strain (PACS) by two-dimensional speckle-tracking echocardiography.
Time to first atrial fibrillation recurrenceFrom day 91 to 12 months after ablationTime from the end of the blanking period to the first documented atrial arrhythmia episode \>=30 seconds.
Atrial fibrillation burden3, 6, and 12 monthsPercentage of time in atrial fibrillation on 24-hour Holter monitoring
Use of antiarrhythmic drugs after the blanking periodFrom day 91 to 12 months after ablationProportion of participants requiring antiarrhythmic drug therapy after the 90-day blanking period.
HospitalizationUp to 12 months after ablationNumber of participants with all-cause and cardiovascular hospitalization
Repeat ablation or cardioversionUp to 12 months after ablationProportion of participants undergoing repeat catheter ablation or cardioversion for recurrent atrial arrhythmia.

Countries

Taiwan

Contacts

CONTACTChaoyu Chen
oripast@gmail.com886-6-2353535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026