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

JRCT ID: jRCTs031220608

Registered date:06/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atrial Fibrillation (AF), Diabetes Mellitus (DM)
• Date of first enrollment: 18/05/2023
• Target sample size: 128
• Study type: Interventional
• Intervention(s): SGLT2 inhibitor

Outcome(s)

• Primary Outcome: AF free survival rate at 48 weeks after catheter ablation
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude criteria

1)Type1 DM
2)HbA1c >10.0%
3)SGLT-2 inhibitor or insulin therapy within 1 week
4)High risk patients for hypoglycemia (pituitary insufficiency, adrenal insufficiency, excessive alcohol intake)
5)eGFR <30mL/min/1.73m2
6)Systolic BP <90mmHg, >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

Related Information

• Primary Sponsor: Matsumoto Hiroki
• Secondary Sponsor: Kowa company, Ltd