The effect of SGLT-2 inhibitor in patient with atrial fibrillation and diabetes mellitus

Ewha Womans University Medical Center0 个研究点目标入组 720 人开始时间: 待定最近更新: 2021年12月2日

适应症

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•At least 20 years old, but not older than 80 years.
•Type 2 DM was diagnosed (HbA1c > 6.5%) and the patient who meets the criteria
•- HbAc > 7.5% who are not administered oral hyperglycemic agent
•- HbAc > 7.5% who are administered oral hyperglycemic agent(s) more than 3 months
•At least one episode of atrial fibrillation that is documented during the prior year by any kind of ECG recording.

•Under 20 years old or over 80 years
•Subject for another clinical trial within the past 2 months
•Any disease that limits life expectancy to under 1 year
•Pregnant women, Lactating women
•HbA1c = 12% or HbA1c < 6.5% at diagnosis
•Diagnosis of Type 1 DM, MODY, or secondary DM
•Type 2 DM treated by recombinant insulin
•Previous treatment with any SGLT2 inhibitor
•Chronic cystitis and/or recurrent genitourinary tract infections (3 or more in the last year)
•Unexplained hematuria at baseline study
•Systolic BP > 180 mmHg or diastolic BP > 100 mmHg at baseline study
•Systolic BP < 95 mmHg at baseline study
•Acute cardiovascular event [e.g., stroke, acute coronary syndrome (ACS), revascularization, decompensated HF, sustained ventricular tachycardia, return f spontaneous circulation (ROSC)] <8 weeks prior to baseline study
•Severe valvular disease or have prosthetic valve
•Renal dysfunction (eGFR-CKD-EPI < 45 mL/min/1.73 m^2)
•Clinically profound hepatic dysfunction
•Clinically uncontrolled thyroid dysfunction
•History of any malignancy within 5 years
•Treatment with chronic oral steroid (>30 consecutive days) at a dose equivalent to oral prednisolone = 10 mg/d, within the past 1 month

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