None listed
Conditions
Interventions
Drug : Experimental group: Envlo tablet 0.3mg, 1T, once a day, 2 years, oral administration
Control group: Envlo placebo tablets, 1 T, once a day, 2 years, oral administration
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals who understand the study protocol and have provided written informed consent 2. Adult men and women aged 19 to 85 years 3. Moderate or asymptomatic severe AS i) Aortic valve area (AVA) <1.5 cm², aortic valve peak velocity (Vmax) = 3 m/s, or aortic valve mean pressure gradient (meanPG) = 25 mmHg ii) Left ventricular ejection fraction = 50% iii) Asymptomatic: New York Heart Association (NYHA) functional class I
Exclusion criteria
Exclusion criteria: 1. Patients with a left ventricular ejection fraction of less than 50% 2. Patients who meet the indications for aortic valve surgery according to the ACC and ESC guidelines 3. Symptomatic severe aortic stenosis 4. Patients with severe stenosis or regurgitation in other valves, or those with concomitant severe aortic regurgitation 5. Very severe aortic stenosis (Very severe AS): AV Vmax = 5 m/s or AV mean PG = 50 mmHg 6. NYHA Class II–IV 7. History of SGLT2i use within the past 3 months 8. Hypersensitivity to SGLT2 inhibitors 9. Estimated glomerular filtration rate < 30 mL/min/1.73 m² or currently on dialysis 10. Type 1 diabetes 11. Pregnancy or breastfeeding 12. Liver disease with AST or ALT levels = 2 times the upper limit of normal, history of hepatic encephalopathy, history of esophageal varices, or history of portosystemic shunt surgery 13. Life expectancy of less than 1 year or inability to comply with the clinical trial protocol 14. Diabetic ketoacidosis 15. Patients currently taking medications that may affect efficacy (DPP-4 inhibitors, vitamin K, calcium supplements) 16. Sexually active women of childbearing potential who do not agree to use appropriate contraception to prevent pregnancy during the trial period 17. Participants who have participated in another clinical trial within the past month or within 5 times the half-life 18. Participants with a history of malignant tumors within the past 5 years as of the screening visit (within the past 3 years for borderline cancers)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of major cardiovascular events (all-cause death, aortic valve replacement, hospitalization for heart failure) from the enrollment date through the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality from the enrollment date through the end of the study;Aortic valve replacement from the enrollment date through the end of the study;Hospitalization for heart failure from the enrollment date through the end of the study;Cardiac death from the enrollment date through the end of the study;Severity of aortic stenosis on echocardiography from the enrollment date through the end of the study;Difference of change in myocardial mass on echocardiography from the date of enrollment to the end of the study ;Differences in changes in Global longitudinal strain on echocardiography from the date of enrollment to the end of the study;Differences in changes in left ventricular ejection fraction on echocardiography from the date of enrollment to the end of the study;Differences in changes in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels from the date of enrollment to the end of the study;Difference in the average rate of change in estimated annual glomerular filtration rate (CKD-EPI) from the date of enrollment to the end of the study;Adverse drug reactions to Sodium glucose cotransporter-2 inhibitor from the enrollment date through the end of the study | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-Ji Park
Samsung Medical Center
Outcome results
None listed