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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Chest Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years;

Disqualifiers

Duration of persistent AF >5 years;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin (10Mg Tab) along with standard medical therapy

    Drug

    Dapagliflozin 10 mg per day for 3 months after initial catheter ablation

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: DapagliflozinExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Atrial fibrillation burden at 3 months after ablation

Atrial fibrillation burden is defined as the percent of time spent in atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) episodes detected by 7-day single-lead ECG patches at 3 months after ablation.

Time frame
3 months

Secondary outcomes

1

Atrial fibrillation recurrence during 3 months after ablation

Atrial fibrillation recurrence is defined as the first recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting 30 seconds or longer detected by ECG during 3 months after ablation.

Time frame
3 months
2

Changes of quality of life at 3 months

Changes of quality of life from baseline to 3 months after ablation evaluated by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire.

Time frame
3 months
3

Atrial fibrillation recurrence during 1 year after ablation

Atrial fibrillation recurrence is defined as the first recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting 30 seconds or longer detected by ECG during 1 year after ablation.

Time frame
1 year

Other outcomes

Sponsors and contacts

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