Not Yet RecruitingNot Applicable

Epicardial Adipose Tissue-Targeted DApagliflozin for Reducing Electrical Remodeling in Atrial Fibrillation

China280 participantsStarted 2026-01-01

Plain-language summary

Persistent atrial fibrillation (PeAF) is associated with a high risk of recurrence following catheter ablation despite advances in ablation technology and strategies. Beyond electrophysiological mechanisms, increasing evidence suggests that atrial structural and inflammatory remodeling plays a pivotal role in the initiation and maintenance of AF, particularly in persistent forms. Epicardial adipose tissue (EAT) is a metabolically active visceral fat depot located between the myocardium and visceral pericardium. EAT shares a common microcirculation with the underlying atrial myocardium and exerts paracrine and vasocrine effects through the secretion of pro-inflammatory cytokines, adipokines, and profibrotic mediators. Increased EAT volume or thickness has been consistently associated with AF burden, atrial fibrosis, left atrial enlargement, and a higher risk of AF recurrence after catheter ablation. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have demonstrated pleiotropic cardiovascular benefits beyond glucose lowering, including reduction in visceral adiposity, attenuation of systemic and local inflammation, and favorable effects on cardiac remodeling. Observational studies and randomized trials in patients with diabetes or heart failure suggest that SGLT2i therapy reduces incident AF and AF recurrence after ablation. However, the effect of SGLT2i in non-diabetic, non-heart failure patients-particularly those with increased EAT as a distinct pathophysiological substrate-remains unclear.This trial is designed to evaluate whether dapagliflozin, administered peri-ablation, can reduce atrial arrhythmia recurrence in PeAF patients with increased EAT but without class I indications for SGLT2i. This targeted approach aims to provide mechanistic and clinical evidence supporting metabolic-inflammatory modulation as an adjunctive strategy to catheter ablation.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-80 years; Diagnosis of persistent atrial fibrillation (continuous AF \>7 days and ≤5 years); Planned first-time catheter ablation for AF; No class I indications for dapagliflozin, defined as: No diabetes mellitus; No history of heart failure (HFrEF, HFmrEF, or HFpEF); No chronic kidney disease (eGFR ≥60 mL/min/1.73 m²); Evidence of increased epicardial adipose tissue on cardiac CT or cardiac MRI, defined according to pre-specified imaging thresholds; Ability to provide written informed consent. Exclusion Criteria: * Duration of persistent AF \>5 years; Left atrial anteroposterior diameter \>50 mm on transthoracic echocardiography; Prior AF catheter ablation or surgical ablation; Current or recent (within 3 months) use of any SGLT2 inhibitor; Severe structural heart disease (e.g., hypertrophic cardiomyopathy, rheumatic valvular disease, dilated cardiomyopathy); Contraindications to catheter ablation (e.g., left atrial thrombus, active infection); Estimated glomerular filtration rate \<60 mL/min/1.73 m²; Type 1 diabetes or history of diabetic ketoacidosis; Pregnancy or breastfeeding; Any condition deemed by investigators to make study participation inappropriate.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Atrial fibrillation burden at 3 months after ablation

Timeframe: 3 months

Trial details

NCT IDNCT07331727

SponsorShanghai Chest Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Atrial Fibrillation (AF) trials