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

Matsumoto Hiroki0 个研究点目标入组 128 人开始时间: 2023年2月6日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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

•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

发起方

Matsumoto Hiroki