Finerenone After Catheter Ablation to Reduce Atrial Fibrillation Recurrence

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNational Cheng-Kung University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: FinerenoneExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

Time to first atrial fibrillation recurrence

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

Time frame
From day 91 to 12 months after ablation
2

Atrial fibrillation burden

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

Time frame
3, 6, and 12 months
3

Use of antiarrhythmic drugs after the blanking period

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

Time frame
From day 91 to 12 months after ablation
4

Repeat ablation or cardioversion

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

Time frame
Up to 12 months after ablation

Other outcomes

1

Change in NT-proBNP by clinical laboratory immunoassay

Changes in NT-proBNP measured by clinical laboratory immunoassay

Time frame
Baseline, 1 month, 6 months, and 12 months
2

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

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.

Time frame
Baseline, 6 months, and 12 months
3

Changes in hsCRP by clinical laboratory immunoassay

Changes in hsCRP measured by clinical laboratory immunoassay

Time frame
Baseline, 1 month, 6 months, and 12 months
4

Changes in TGF-beta by ELISA

Changes in TGF-beta measured by ELISA

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.