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NCT Number: NCT06111443

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

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.

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Key information

Conditions

Atrial Fibrillation Recurrent Catheter Ablation

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Kaoshiung Chang Gung Memorial

Kaohsiung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dapagliflozin 10 mg [Farxiga]

Drug

Dapagliflozin 10 mg [Farxiga] for 3 months after catheter ablation of atrial fibrillation

Primary outcomes

  1. Freedom from all atrial tachyarrhythmias (AF/AFL/AT)

    Time frame: 3,6 and 12 months after ablation

    Freedom from all atrial tachyarrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 7-day Holter test at 3, 6, and 12-month follow-up) and 12-lead electrocardiogram (ECG) performed at cardiovascular (CV) outpatient department (OPD) follow-up within one-year post catheter ablation. (unit: %)

Secondary outcomes

  1. Freedom from all atrial tachyarrhythmias (AF/AFL/AT) excluding the 3-month blanking period

    Time frame: 6 and12 months after ablation

    Freedom from all atrial tachyarrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 7-day Holter at 6 and 12-month follow-up) and 12-lead ECG performed at CV OPD follow-up since 3 months post catheter ablation within one year post catheter ablation. (a conventional 3-month blanking period from catheter ablation was used in both groups during which arrhythmia recurrences were not counted toward the recurrent endpoint) (unit: %)

  2. Freedom from all atrial tachyarrhythmias (AF/AFL/AT) within 3-month blanking period

    Time frame: 3 months after ablation

    Freedom from all atrial tachyarrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 7-day Holter at 3-month follow-up) or 12-leads ECG within 3 months following index ablation (within blanking period) (unit: %)

  3. Total mortality or hospitalization due to CV cause

    Time frame: 12 months after ablation

    Total mortality or hospitalization due to cardiovascular cause within one year after ablation (unit: %)

  4. Left atrial (LA) size (LA dimension and LA volume index) by echocardiography

    Time frame: 6 and 12 months

    Left atrial (LA) size (LA dimension in mm and LA volume index in mL/m2) by echocardiography at 6 and 12 months

  5. AF quality of life (QOL) by AF Effect On Quality-Of-Life (AFEQT) questionnaire score

    Time frame: 1,3,6,9 and 12 months

    Change in AF QOL at 1 month, 3 months, 6 months, 9 months and 12 months after receiving catheter ablation relative to baseline: defined as a change in AF QOL assessed in the validated AFEQT questionnaire score. (no unit)

  6. N-terminal pro-brain natriuretic peptide (NT-proBNP) level

    Time frame: 3 and 12 months

    Blood test for plasma NT-proBNP level in pg/ml

  7. Glycated Hemoglobin (HBA1c)

    Time frame: 3 and 12 months

    HBA1c in %, serum creatinine in mg/dl

  8. Creatinine (Cr) and estimated Glomerular filtration rate (eGFR)

    Time frame: 3 and 12 months

    serum Cr in mg/dl, estimated Glomerular filtration rate (eGFR) by MDRD formula in ml/min per 1.73 m2 (calculated according to serum Cr, age, and sex)

  9. Urine albumin/Cr ratio level

    Time frame: 3 and 12 months

    Urine albumin/Cr ratio in mg/g

  10. Repeated catheter ablation or cardioversion for atrial tachyarrhythmia

    Time frame: 12 months

    Repeated catheter ablation or cardioversion for atrial tachyarrhythmia within one year (unit: %)

  11. Adverse events: hypoglycemia, hypotension, hypokalemia, renal function deterioration

    Time frame: 12 months

    Adverse events: hypoglycemia, hypotension, hypokalemia, renal function deterioration (defined as decline in the estimated GFR of at least 50%) (unit:%)

  12. AF burden

    Time frame: 3,6 and 12 months

    AF burden in % documented by 7-day Holter at 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2023
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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