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

Phase 4

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

• Registration Number: JPRN-jRCTs031220608
• Lead Sponsor: Matsumoto Hiroki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 128

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AF free survival rate at 48 weeks after catheter ablation

Secondary Outcome Measures

Name	Time	Method
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)