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

Phase 3Active Not RecruitingNCT06111443

Chang Gung Memorial Hospital196 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

196

Conditions

Atrial Fibrillation Recurrent

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

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: %)

Time frame: 3,6 and 12 months after ablation

Secondary Outcomes

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

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: %)

Time frame: 6 and12 months after ablation

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

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: %)

Time frame: 3 months after ablation

Total mortality or hospitalization due to CV cause

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

Time frame: 12 months after ablation

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

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

Time frame: 6 and 12 months

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

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)

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

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

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

Time frame: 3 and 12 months

Glycated Hemoglobin (HBA1c)

HBA1c in %, serum creatinine in mg/dl

Time frame: 3 and 12 months

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

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)

Time frame: 3 and 12 months

Urine albumin/Cr ratio level

Urine albumin/Cr ratio in mg/g

Time frame: 3 and 12 months

Repeated catheter ablation or cardioversion for atrial tachyarrhythmia

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

Time frame: 12 months

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

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

Time frame: 12 months

AF burden

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

Time frame: 3,6 and 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes