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Recruiting Phase 4

ENavogliflozin DElivering Alleviation of Ventricular Diastolic Dysfunction in nonObstRuctive Hypertrophic CardioMyopathy

NCT06580717 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 4
Started
2024-10-15
Last updated
2024-11-08

Condition(s) studied

Nonobstructive Hypertrophic Cardiomyopathy

Investigational drug(s) / intervention(s)

enavogliflozin 0.3mg →enavogliflozin Placebo

enavogliflozin 0.3mg: Enavogliflozin 0.3mg, 1 tablet once a day, is prescribed for a period of 24 weeks. Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of enavogliflozin 0.3 mg once daily or placebo.

enavogliflozin Placebo: A placebo pill identical to enavogliflozin, 1 tablet once a day, is prescribed for a period of 24 weeks. Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of enavogliflozin 0.3 mg once daily or placebo.

Study summary

The primary objective of this study is to investigate the effect of enavogliflozin, an Sodium-glucose transporter 2 (SGLT2) inhibitor, compared with placebo on left ventricular diastolic function in patients with nonobstructive hypertrophic cardiomyopathy. The secondary objective of this study is to investigate the effect of enavogliflozin on exercise capacity, symptoms, serum biomarkers, and arrhythmic burden in patients with nonobstructive hypertrophic cardiomyopathy.

Eligibility

Sex
ALL
Min age
19 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. A patient 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 Renin-angiotension-system(RAS) blockers (beta-blocker, non-dihydropyridine Calcium Cannel Blocker, 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. New York Heart Association (NYHA) Class 1\~3 Exclusion Criteria: 1. History of hypersensitivity to clinical trial drugs 2. If you are currently taking Sodium-glucose transporter 2 (SGLT2) inhibitors or within 4 weeks \- For diabetic patients, any type of hypoglycemic agent other than Sodium-glucose transporter 2 (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. ASpartate Transaminase(AST) or ALanine Transaminase(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. New York Heart Association (NYHA) class 4

Primary outcome measure(s)

  • Change from baseline in left ventricular diastolic reserve (Δe') assessed by diastolic stress echocardiography — 24 weeks, 52 weeks
    This variable will be assessed by diastolic stress echocardiography and compared to baseline values at 24 weeks (end of study) This variable will be assessed by diastolic stress echocardiography and compared to baseline values at 52 weeks (post-trial 24 weeks). This variable will be assessed by diastolic stress echocardiography and compared to 24 weeks (end of study) values at 52 weeks (post-trial 24 weeks).

Trial sites (1)

FacilityCityRegionStatus
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06580717 on ClinicalTrials.gov ↗ ← All trials in South Korea