sodium-glucose cotransporter 2 inhibitor in catheter ablation for atrial fibrillation

The evaluation of recurrence inhibition of atrial fibrillation with sodium-glucose cotransporter 2 inhibitor after catheter ablation in atrial fibrillation patients with type 2 diabetes: open-label, randomized, active controlled, clinical study - TOP-AF

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031220608

Enrollment

128

Registered

2023-02-06

Start date

2023-05-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF), Diabetes Mellitus (DM) HbA1c, AF burden, NT-proBNP, Left atrial volume (LA volume), Left ventricular ejection fraction (LVEF)

Interventions

SGLT2 inhibitor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)20-79 years old 2)Paroxysmal or persistent AF 3)Patients with diabetes mellitus under diet/exercise therapy for more than 4 weeks or under the treatment with oral hypoglycemic agents 4)The first AF ablation 5)Informed consent with the change in the treatment of diabetes mellitus

Exclusion criteria

Exclusion criteria: 1)Type1 DM 2)HbA1c >10.0% 3)SGLT-2 inhibitor or insulin therapy within 3 days 4)High risk patients for hypoglycemia (pituitary insufficiency, adrenal insufficiency, excessive alcohol intake) 5)eGFR 180mmHg, diastolic BP >110mmHg 7)Cardiac surgery (open heart surgery, pacemaker implantation, percutaneous coronary intervention) within 3 months 8)NYHA 3-4 9)Severe valvular heart disease 10)Life-threatening malignancy, severe COPD with oxygen inhalation of specific medication, end-stage renal disease with dialysis, hyperthyroidism 11)Difficulty with oral water intake 12)History of hypersensitivity with the ingredients of tofogliflozin 13)Diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic nonketoic coma (HONK) 14)Severe infectious disease 15)Severe traumatic disease 16)Incapacity to give informed consent 17)Pregnancy 18)Major complications after catheter ablation 19)Ineligible patients judged by investigators

Design outcomes

Primary

Measure	Time frame
AF free survival rate at 48 weeks after catheter ablation	—

Secondary

Measure	Time frame
AF burden, LA diameter (LAD), Left ventricular ejection fraction (LVEF), LA volume index (LAVI), E/e', NT-proBNP, BMI, Systolic/Diastolic blood pressure, HbA1c, A high-sensitivity C-reactive protein (hs-CRP), inflammatory cytokines (IL-6), Serum creatinine (S-Cre), estimated glomerular filtration rate (eGFR)	—

Contacts

Public ContactHiroki Matsumoto

Juntendo University Hospital

hmatsumo@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026