Impact of sodium-glucose transportation protein 2 inhibitor therapy on Diastolic hEart function and left AtriaL pressure in Atrial Fibrillatio

Not Applicable

Recruiting

Conditions: Diseases of the circulatory system

Registration Number: KCT0005166

Lead Sponsor: Asan Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

?Subjects with = 19 years of age
?Documented atrial fibrillationon any form of electrocardiography.
?Type 2 diabetes mellitus by American diabetic association diagnostic criteria (Fasting glucose=126mg/dL or 2-h PG=200mg/dL or HbA1C >6.5%)
?HbA1C =7.5% before oral hypoglycemic agent or HbA1C 7.0-10.0% with one or more oral hypoglycemic agent (metformin or sulfonylurea)
?Agreement with protocol and providing informed consent

Exclusion Criteria

?Subject with conflict of interest
?The subject who unable to provide informed consent or participating in the follow-up.
?Prior use of sodium-glucose transport protein-2 inhibitor or Dipeptidyl peptidase-4 inhibitor
?HbA1C = 10% or requiring insulin therapy for glucose management
?Contraindications to the sodium-glucose transport protein-2 inhibitor or Dipeptidyl peptidase-4 inhibitor (hypersensitivity or Creatinine clearance < 30ml/min)
?Active liver disease or laboratory abnormality (ALT or AST > x3 normal range)
?Severe congestive heart failure (New York Heart associationClass III or IV)
?Underlying conditions affect the primary outcome of the study (E/e') - Uncontrolled tachycardia, Mitral stenosis or regurgitation, prior mitral surgery, calcification of mitral annulus, left bundle branch block, aortic regurgitation
?Active malignancy.
?Pregnant and or lactating women
?Life expectancy < 1 year
? Not suitable for participation by the investigator's discretion

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of E/e' in the 10-month follow-up echocardiography compared to the baseline

Secondary Outcome Measures

Name	Time	Method
Major coronary and cerebrovascular event (death, myocardial infarction, stroke);heart failure hospitalization;Parameters of diastolic dysfunction (Mitral valve deceleration time, Tricuspid regurgitation grade, Tricuspid regurgitation maximal velocity, left atrial diameter, Left ventricular mass index, global left ventricular strain)