Clinical trial NCT06111443: Effect of Dapagliflozin on the Recurrence of Atrial Tachyarrhythmia in Patients Undergoing Catheter Ablation of Atrial Fibrillation
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Atrial Fibrillation Recurrent
Catheter Ablation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 196
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Freedom from all atrial tachyarrhythmias (AF/AFL/AT)
timeFrame: 3,6 and 12 months after ablation
Secondary outcomes:
measure: Freedom from all atrial tachyarrhythmias (AF/AFL/AT) excluding the 3-month blanking period
timeFrame: 6 and12 months after ablation
measure: Freedom from all atrial tachyarrhythmias (AF/AFL/AT) within 3-month blanking period
timeFrame: 3 months after ablation
measure: Total mortality or hospitalization due to CV cause
timeFrame: 12 months after ablation
measure: Left atrial (LA) size (LA dimension and LA volume index) by echocardiography
timeFrame: 6 and 12 months
measure: AF quality of life (QOL) by AF Effect On Quality-Of-Life (AFEQT) questionnaire score
timeFrame: 1,3,6,9 and 12 months
measure: N-terminal pro-brain natriuretic peptide (NT-proBNP) level
timeFrame: 3 and 12 months
measure: Glycated Hemoglobin (HBA1c)
timeFrame: 3 and 12 months
measure: Creatinine (Cr) and estimated Glomerular filtration rate (eGFR)
timeFrame: 3 and 12 months
measure: Urine albumin/Cr ratio level
timeFrame: 3 and 12 months
measure: Repeated catheter ablation or cardioversion for atrial tachyarrhythmia
timeFrame: 12 months
measure: Adverse events: hypoglycemia, hypotension, hypokalemia, renal function deterioration
timeFrame: 12 months
measure: AF burden
timeFrame: 3,6 and 12 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaoshiung Chang Gung Memorial
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yung-Lung Chen
role: PRINCIPAL_INVESTIGATOR
References: