Atrial Fibrillation (AF)Phase 2FINE-CANCT07799519
Finerenone After Catheter Ablation to Reduce Atrial Fibrillation Recurrence
A Phase 2 study testing Finerenone in people with Atrial Fibrillation (AF), run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Finerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jun 2026to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
Chaoyu Chen, 886-6-2353535, oripast@gmail.com
About this study
Official 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
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.
Read the 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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Finerenone
- Keywords
- Finerenone, Catheter ablation, Epicardial adipose tissue, UCP1
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
Also called Karendia
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Finerenone |
| Usual care | No intervention | Following successful pulmonary vein isolation, participants receive standard-of-care post-ablation management without finerenone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From day 91 (end of the 90-day blanking period) to 12 months after ablation
Secondary outcomes (10)
Time to first atrial fibrillation recurrence
Time from the end of the blanking period to the first documented atrial arrhythmia episode >=30 seconds.
Measured: From day 91 to 12 months after ablation
Atrial fibrillation burden
Percentage of time in atrial fibrillation on 24-hour Holter monitoring
Measured: 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.
Measured: 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.
Measured: Up to 12 months after ablation
Hospitalization
Number of participants with all-cause and cardiovascular hospitalization
Measured: 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
Measured: 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.
Measured: Baseline to 12 months
Change in epicardial adipose tissue mean attenuation on cardiac CT
Change in EAT mean attenuation (HU)
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start9 Jun 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799519
- Sponsor's protocol ID
- NCKUH-11502012
- Other IDs
- NCKUH-11502012
- Acronym
- FINE-CA
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07799519
- Acronym / sponsor ID
- FINE-CA / NCKUH-11502012
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Finerenone, Catheter ablation, Epicardial adipose tissue, UCP1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finerenone | Experimental | Drug: FinerenoneFollowing 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. |
| Usual care | No intervention | –Following successful pulmonary vein isolation, participants receive standard-of-care post-ablation management without finerenone. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinerenoneAlso: KarendiaOral 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. | Drug | Finerenone |
Primary outcome
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.
10 secondary outcomes
Time to first atrial fibrillation recurrence
Time frame: From day 91 to 12 months after ablation
Atrial fibrillation burden
Time frame: 3, 6, and 12 months
Use of antiarrhythmic drugs after the blanking period
Time frame: From day 91 to 12 months after ablation
Repeat ablation or cardioversion
Time frame: Up to 12 months after ablation
Hospitalization
Time frame: Up to 12 months after ablation
Safety: incidence of adverse events
Time frame: Up to 12 months after ablation
Change in epicardial adipose tissue volume on cardiac CT
Time frame: Baseline to 12 months
Change in epicardial adipose tissue mean attenuation on cardiac CT
Time frame: Baseline to 12 months
Change in serum uncoupling protein-1 (UCP1) concentration by ELISA
Time frame: Baseline, 1 month, 6 months, and 12 months
Change in left atrial strain parameters by two-dimensional speckle-tracking echocardiography
Time frame: Baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: 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.
Related trials for Atrial Fibrillation (AF)
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Finerenone in people with Atrial Fibrillation (AF), run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chaoyu Chen (886-6-2353535, oripast@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation recurrence after the blanking period (time frame: From day 91 (end of the 90-day blanking period) to 12 months after ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.