None listed
Conditions
Interventions
Drug : A total of 200 patients will be included, and patients who meet the study subject selection and exclusion criteria will be randomly assigned to a group receiving oral enavogliflozin 0.3 mg once
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A person who understands the research protocol and fills out a consent form 2. Adults over 19 years of age and under 80 years of age 3. Non-diabetic or type 2 diabetic patients (HbA1c 6.5-10.5%) 4. Patients with non-obstructive hypertrophic cardiomyopathy who do not show significant dynamic left ventricular outflow tract obstruction at rest or during Valsalva maneuver or exercise stress on echocardiography within 3 months of the screening visit. - Non-obstructive hypertrophic cardiomyopathy: corresponds to maximum left ventricular outflow tract pressure gradient <30mmHg. - Maximum left ventricular wall thickness =15mm if there is no family history of hypertrophic cardiomyopathy, or maximum left ventricular wall thickness =13mm if there is a family history of hypertrophic cardiomyopathy or positive for related genetic mutation. 5. For hypertrophic cardiomyopathy, existing beta blockers, calcium channel blockers, diuretics and RAS blockers (beta-blocker, non-DHP CCB, loop diuretics, thiazide and thiazide-like diuretics, mineralocorticoid receptor antagonist, angiotensin converting enzyme inhibitor/angiotensin) For patients using receptor blocker/angiotensin receptor neprilysin inhibitor), the drug dose was stable for 2 weeks before screening and no change in dose is expected throughout the study period. 6. Women of childbearing age who agree to use contraception (hormones, intrauterine device, tubal ligation, spouse's vasectomy, etc.) for 30 days from the time of screening, during the clinical trial period, and after taking the clinical trial drug. 7. NYHA Class 1~3
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to clinical trial drugs 2. If you are currently taking SGLT-2 inhibitors or within 4 weeks - For diabetic patients, any type of hypoglycemic agent other than SGLT2 inhibitors can be used. 3. Patients who cannot undergo diastolic stress echocardiography 4. Patients on dialysis or with chronic renal failure with an estimated glomerular filtration rate <30 mL/min/1.73m2 5. Patients with Cardiac implantable electronic device (CIED) 6. Currently pregnant or lactating 7. AST or ALT value more than 3 times the upper limit of normal during liver function test, history of hepatic coma, history of esophageal varices, history of porto-caval anastomosis. 8. Uncontrolled hypertension (SBP=180mmHg or DBP=110mmHg) or severe hypotension (SBP<90mmHg) 9. Severe aortic or mitral stenosis with the possibility of surgery during the clinical trial period 10. Those waiting for a heart transplant or those who have received a heart transplant 11. Persons with diseases that need to be differentiated from heart failure symptoms at the investigator’s discretion, such as severe anemia (hemoglobin <7 g/dL), uncontrolled arrhythmia, severe lung disease, etc. 12. If you have cancer undergoing chemotherapy/radiation/surgical treatment or if your life expectancy is expected to be less than 1 year. 13. Untreated alcohol or drug abuse 14. If you are participating in the administration of another clinical trial drug or clinical trial device test, or have completed participation for less than 30 days. 15. Patients with type 1 diabetes or diabetic ketoacidosis 16. NYHA class 4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mprovement of left ventricular diastolic function: change in diastolic reserve (?e’) | — |
Secondary
| Measure | Time frame |
|---|---|
| Diastolic stress echocardiography and exercise stress cardiopulmonary function test - maximum oxygen demand (VO2max);Diastolic stress echocardiography and exercise stress cardiopulmonary function test - Exercise capacity (METs), time spent exercising;Diastolic stress echocardiography and exercise stress cardiopulmonary function test - Left ventricle and left atrium myocardial strain;Diastolic stress echocardiography and exercise stress cardiopulmonary function test - Left ventricular diastolic function indices (e’, E/e’, PASP, etc.);Diastolic stress echocardiography and exercise stress cardiopulmonary function test - Left ventricular mass index, left ventricle or left atrium size;Blood biomarkers: NT-proBNP, troponin T;Symptoms: NYHA functional class and symptom survey (e.g. KCCQ [Kansas City Cardiomyopathy Questionnaire]);24 hour ambulatory electrocardiogram (24 hour Holter monitoring): Quantification of arrhythmias such as APC, VPC, AF, etc.;Diastolic reserve and other measurements from symptom and diastolic stress echocardiography | — |
Countries
Korea, Republic of
Contacts
Public ContactJihyun Hyung
Yonsei University Health System, Severance Hospital
Outcome results
None listed