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NCT Number: NCT07799519

Finerenone After Catheter Ablation to Reduce Atrial Fibrillation Recurrence

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location status: Recruiting

Location contact

Chaoyu Chen

CONTACT

[email protected]

886-6-2353535

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Karendia

Primary outcomes

  1. Atrial fibrillation recurrence after the blanking period

    Time frame: From day 91 (end of the 90-day blanking period) to 12 months after ablation

    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

  1. Time to first atrial fibrillation recurrence

    Time frame: From day 91 to 12 months after ablation

    Time from the end of the blanking period to the first documented atrial arrhythmia episode >=30 seconds.

  2. Atrial fibrillation burden

    Time frame: 3, 6, and 12 months

    Percentage of time in atrial fibrillation on 24-hour Holter monitoring

  3. Use of antiarrhythmic drugs after the blanking period

    Time frame: From day 91 to 12 months after ablation

    Proportion of participants requiring antiarrhythmic drug therapy after the 90-day blanking period.

  4. Repeat ablation or cardioversion

    Time frame: Up to 12 months after ablation

    Proportion of participants undergoing repeat catheter ablation or cardioversion for recurrent atrial arrhythmia.

  5. Hospitalization

    Time frame: Up to 12 months after ablation

    Number of participants with all-cause and cardiovascular hospitalization

  6. Safety: incidence of adverse events

    Time frame: Up to 12 months after ablation

    Incidence of adverse events, including hyperkalemia (serum potassium >5.5 mmol/L), hypotension, and worsening renal function

  7. Change in epicardial adipose tissue volume on cardiac CT

    Time frame: Baseline to 12 months

    Change in total EAT volume (cm3), defined as contiguous voxels with attenuation between -190 and -15 Hounsfield units within the pericardial contour.

  8. Change in epicardial adipose tissue mean attenuation on cardiac CT

    Time frame: Baseline to 12 months

    Change in EAT mean attenuation (HU)

  9. Change in serum uncoupling protein-1 (UCP1) concentration by ELISA

    Time frame: Baseline, 1 month, 6 months, and 12 months

    Change in circulating UCP1 measured by ELISA, as a peripheral biomarker of adipose tissue browning.

  10. Change in left atrial strain parameters by two-dimensional speckle-tracking echocardiography

    Time frame: Baseline, 6 months, and 12 months

    Change in peak atrial longitudinal strain (PALS) and peak atrial contractile strain (PACS) by two-dimensional speckle-tracking echocardiography.

Other outcomes

  1. Change in NT-proBNP by clinical laboratory immunoassay

    Time frame: Baseline, 1 month, 6 months, and 12 months

    Changes in NT-proBNP measured by clinical laboratory immunoassay

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

    Time frame: Baseline, 6 months, and 12 months

    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.

  3. Changes in hsCRP by clinical laboratory immunoassay

    Time frame: Baseline, 1 month, 6 months, and 12 months

    Changes in hsCRP measured by clinical laboratory immunoassay

  4. Changes in TGF-beta by ELISA

    Time frame: Baseline, 1 month, 6 months, and 12 months

    Changes in TGF-beta measured by ELISA

  5. Changes in PINP by ELISA

    Time frame: Baseline, 1 month, 6 months, and 12 months

    Changes in PINP measured by ELISA

  6. Changes in PIIINP by ELISA

    Time frame: Baseline, 1 month, 6 months, and 12 months

    Changes in PIIINP measured by ELISA

Study contacts

Contact information is provided by the study sponsor or research team.

Chaoyu Chen

CONTACT

[email protected]

886-6-2353535

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Acronym: FINE-CA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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