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

Last updated: December 19, 2023
Sponsor: Chang Gung Memorial Hospital
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Cardiac Disease

Chest Pain

Fast Heart Rate (Tachycardia)

Treatment

Dapagliflozin 10 mg [Farxiga]

Clinical Study ID

NCT06111443
CPRPG8N0011
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Receiving therapy with a sodium-glucose cotransporter 2 (SGLT2) inhibitor prior torandomization, or intolerance to an SGLT2 inhibitor.
  • Type 1 diabetes mellitus
  • Acute coronary syndrome, coronary revascularization (percutaneous coronaryintervention or Coronary artery bypass grafting), ablation of atrialflutter/fibrillation, ischemic stroke, and transient ischemic attack within 12 weeksprior to randomization
  • Active malignancy
  • Women of child-bearing potential who have a positive pregnancy test at randomizationor who are breast-feeding
  • A life expectancy of fewer than 2 years due to any non-cardiovascular condition, basedon the investigator's clinical judgment
  • Expected surgery for structural heart disease, and secondary atrial fibrillation (dueto cardiac surgery, infection, or hyperthyroidism)

Study Design

Total Participants: 196
Treatment Group(s): 1
Primary Treatment: Dapagliflozin 10 mg [Farxiga]
Phase: 2/3
Study Start date:
December 01, 2023
Estimated Completion Date:
November 30, 2026

Study 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.

Connect with a study center

  • Kaoshiung Chang Gung Memorial

    Kaohsiung,
    Taiwan

    Site Not Available

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