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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005166

Enrollment

120

Registered

2020-06-25

Start date

2020-09-02

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : ISGLT-2 inhibitor will be started in the experimental group (Forxiga 10mg, once daily), and DPP-4 inhibitor (Januvia 100mg once daily, Gemiglo 50mg once daily) in the control group. Both medica

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 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

Design outcomes

Primary

Measure	Time frame
Change of E/e' in the 10-month follow-up echocardiography compared to the baseline	—

Secondary

Measure	Time frame
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)	—

Countries

Korea, Republic of

Contacts

Public ContactKee-Joon Choi

Asan Medical Center

kjchoi@amc.seoul.kr+82-2-3010-1586

Outcome results