NCT06111443

Effect of Dapagliflozin on the Recurrence of Atrial Tachyarrhythmia in Patients Undergoing Catheter Ablation of Atrial Fibrillation

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

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This trial is the third phase of random allocation and non-blind trial. It is divided into study group and control group. The study group is Dapagliflozin therapy, and the treatment period is three months post catheter ablation. The control group is usual care (without Dapagliflozin). The follow-up observation period will be one year after catheter ablation. This trial was performed at Kaohsiung Chang Gung Memorial Hospital and Chang Gung Memorial Hospital, Linkou, and Chiayi branches, and it is a multi-center trial. The study flow chart is as follows.

Conditions

• Atrial Fibrillation Recurrent
• Catheter Ablation

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10 mg [Farxiga]	Dapagliflozin 10 mg \[Farxiga\] for 3 months after catheter ablation of atrial fibrillation

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2023-11-01
• Last updated: 2023-12-21

Locations

1 site across 1 country: Taiwan