A Phase 2 interventional study of Finerenone in Atrial Fibrillation (AF), sponsored by National Cheng-Kung University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by National Cheng-Kung University Hospital · Phase 2, Interventional, and Treatment
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.
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 40 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →National Cheng-Kung University Hospital is the lead sponsor of 277 studies on the registry; 70 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Following successful pulmonary vein isolation, participants receive standard-of-care post-ablation management without finerenone.
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
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
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
Atrial fibrillation burden
Percentage of time in atrial fibrillation on 24-hour Holter monitoring
Time frame: 3, 6, and 12 months
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
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
Hospitalization
Number of participants with all-cause and cardiovascular hospitalization
Time frame: Up to 12 months after ablation
Safety: incidence of adverse events
Incidence of adverse events, including hyperkalemia (serum potassium \>5.5 mmol/L), hypotension, and worsening renal function
Time frame: Up to 12 months after ablation
Change in epicardial adipose tissue volume on cardiac CT
Change in total EAT volume (cm3), defined as contiguous voxels with attenuation between -190 and -15 Hounsfield units within the pericardial contour.
Time frame: Baseline to 12 months
Change in epicardial adipose tissue mean attenuation on cardiac CT
Change in EAT mean attenuation (HU)
Time frame: Baseline to 12 months
Change in serum uncoupling protein-1 (UCP1) concentration by ELISA
Change in circulating UCP1 measured by ELISA, as a peripheral biomarker of adipose tissue browning.
Time frame: Baseline, 1 month, 6 months, and 12 months
Change in left atrial strain parameters by two-dimensional speckle-tracking echocardiography
Change in peak atrial longitudinal strain (PALS) and peak atrial contractile strain (PACS) by two-dimensional speckle-tracking echocardiography.
Time frame: Baseline, 6 months, and 12 months
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
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
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
Changes in TGF-beta by ELISA
Changes in TGF-beta measured by ELISA
Time frame: Baseline, 1 month, 6 months, and 12 months
Changes in PINP by ELISA
Changes in PINP measured by ELISA
Time frame: Baseline, 1 month, 6 months, and 12 months
Changes in PIIINP by ELISA
Changes in PIIINP measured by ELISA
Time frame: Baseline, 1 month, 6 months, and 12 months
Plan to share: No — Individual participant data will not be shared publicly due to the small sample size and risk of re-identification; de-identified data may be available from the corresponding author upon reasonable request.
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Studies of the drug tested here: Finerenone
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