ENavogliflozin DElivering Alleviation of Ventricular Diastolic Dysfunction in nonObstRuctive Hypertrophic CardioMyopathy

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Nonobstructive Hypertrophic Cardiomyopathy

In brief

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.

Key facts

Study ID

NCT06580717

Run by

Yonsei University

People needed

200

Starts

2024-10-15

Expected to finish

2026-11-30

Last updated by the study team

2024-11-08

Who can join

Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A patient who understands the research protocol and fills out a consent form
• Adults over 19 years of age and under 80 years of age
• Non-diabetic or type 2 diabetic patients (HbA1c 6.5-10.5%)
• 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.
• 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.
• 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.
• New York Heart Association (NYHA) Class 1\~3

You may not qualify if…

• History of hypersensitivity to clinical trial drugs
• 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.
• Patients who cannot undergo diastolic stress echocardiography
• Patients on dialysis or with chronic renal failure with an estimated glomerular filtration rate <30 mL/min/1.73m2
• Patients with Cardiac implantable electronic device (CIED)
• Currently pregnant or lactating
• 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.
• Uncontrolled hypertension (SBP≥180mmHg or DBP≥110mmHg) or severe hypotension (SBP<90mmHg)
• Severe aortic or mitral stenosis with the possibility of surgery during the clinical trial period
• Those waiting for a heart transplant or those who have received a heart transplant
• 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.
• If you have cancer undergoing chemotherapy/radiation/surgical treatment or if your life expectancy is expected to be less than 1 year.
• Untreated alcohol or drug abuse
• 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.
• Patients with type 1 diabetes or diabetic ketoacidosis
• New York Heart Association (NYHA) class 4

Where it is running

• Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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