Effect of Dapagliflozin on the Recurrence of Atrial Tachyarrhythmia in Patients Undergoing Catheter Ablation of Atrial Fibrillation - A Randomized Open-Label Phase III Trial

CPRPG8N0011

The goal of this clinical trial is to test the effect of Dapagliflozin on the Recurrence of Atrial Tachyarrhythmia in Patients Undergoing Catheter Ablation of Atrial Fibrillation. The main questions it aims to answer are: • If Dapagliflozin will reduce the recurrence of all atrial tachyarrhythmias \[atrial fibrillation (AF), atrial flutter (AFL) and atrial tachycardia (AT)\] greater than 30 seconds during one-year follow-up after catheter ablation. Participants will receive Dapagliflozin (FORXIGA) 10 milligram (mg) once a day (QD) for 3 months after catheter ablation of atrial fibrillation. Researchers will compare patients who receive usual care to see if Dapagliflozin will reduce the recurrence of all atrial tachyarrhythmias (AF/AFL/AT) during one-year follow-up after catheter ablation.

2023-12-01

2026-11-30

2026-11-30

Active (not recruiting)

Early phase I

196

Inclusion Criteria: * Ability to give written informed consent * Men and women age \>= 20 years. * Paroxysmal, persistent or long-standing persistent atrial fibrillation * eGFR \>= 25 ml/min/1.73 m2 Exclusion Criteria: * Receiving therapy with a sodium-glucose cotransporter 2 (SGLT2) inhibitor prior to randomization, or intolerance to an SGLT2 inhibitor. * Type 1 diabetes mellitus * Acute coronary syndrome, coronary revascularization (percutaneous coronary intervention or Coronary artery bypass grafting), ablation of atrial flutter/fibrillation, ischemic stroke, and transient ischemic attack within 12 weeks prior to randomization * Active malignancy * Women of child-bearing potential who have a positive pregnancy test at randomization or who are breast-feeding * A life expectancy of fewer than 2 years due to any non-cardiovascular condition, based on the investigator's clinical judgment * Expected surgery for structural heart disease, and secondary atrial fibrillation (due to cardiac surgery, infection, or hyperthyroidism)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 196, 'type': 'ESTIMATED'}}

2023-12-21