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New treatment option for Nonobstructive Hypertrophic Cardiomyopathy
Official title ENavogliflozin DElivering Alleviation of Ventricular Diastolic Dysfunction in nonObstRuctive Hypertrophic CardioMyopathy
ClinicalTrials.gov ID: NCT06580717
What this study is testing
What is enavogliflozin 0.3mg?
enavogliflozin 0.3mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for nonobstructive hypertrophic cardiomyopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80
You may be able to join 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...
- Non-obstructive hypertrophic cardiomyopathy: corresponds to maximum left ventricular outflow tract pressure gradient \<30mmHg.
You likely can't join 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...
- 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
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- New York Heart Association (NYHA) Class 1\~3
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.