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

Chang Gung Medical Foundation

Status and phase

Active, not recruiting

Phase 3

Phase 2

Conditions

Atrial Fibrillation Recurrent

Catheter Ablation

Treatments

Drug: Dapagliflozin 10 mg [Farxiga]

Study type

Interventional

Funder types

Other

Identifiers

NCT06111443

CPRPG8N0011

Details and patient eligibility

About

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.

Full 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.

Enrollment

196 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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)