The effect of SGLT-2 inhibitor in patient with atrial fibrillation and diabetes mellitus
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0006701
- Lead Sponsor
- Ewha Womans University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 720
•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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method recurrence rate of AF within a year in all participants;recurrence rate of AF within a year in ablated participants
- Secondary Outcome Measures
Name Time Method Atrial fibrillation free survival;Ablation rate;Diameter of left atrium;NT-pro BNP;mEHRA (modified European Heart Rhythm Association) AF symptom score;Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score