Actively Recruiting
ENavogliflozin DElivering Alleviation of Ventricular Diastolic Dysfunction in nonObstRuctive Hypertrophic CardioMyopathy
Led by Yonsei University · Updated on 2024-11-08
200
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ENavogliflozin DElivering Alleviation of Ventricular Diastolic Dysfunction in nonObstRuctive Hypertrophic CardioMyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understands the research protocol and signs a consent form
- Adults aged over 19 and under 80 years
- Non-diabetic or type 2 diabetic patients with HbA1c between 6.5% and 10.5%
- Diagnosed with non-obstructive hypertrophic cardiomyopathy without significant left ventricular outflow obstruction (gradient <30mmHg) within 3 months before screening
- Left ventricular wall thickness ≥15mm without family history or ≥13mm with family history or positive genetic test
- Stable use of beta blockers, calcium channel blockers, diuretics, or renin-angiotensin system blockers for at least 2 weeks before screening with no expected dose changes during the study
- Women of childbearing potential agree to use contraception during and 30 days after the trial
- New York Heart Association (NYHA) Class 1 to 3
You will not qualify if you...
- History of allergy to the study drugs
- Use of SGLT2 inhibitors within 4 weeks before the study
- Unable to undergo diastolic stress echocardiography
- On dialysis or with chronic kidney failure (eGFR <30 mL/min/1.73m2)
- Has a cardiac implantable electronic device
- Currently pregnant or breastfeeding
- Liver enzymes (AST or ALT) more than 3 times the upper limit, history of severe liver disease
- Uncontrolled high blood pressure (SBP ≥180 mmHg or DBP ≥110 mmHg) or severe low blood pressure (SBP <90 mmHg)
- Severe aortic or mitral valve narrowing needing surgery
- Awaiting or having had a heart transplant
- Other serious diseases that mimic heart failure symptoms, such as severe anemia, uncontrolled arrhythmia, or severe lung disease
- Cancer under active treatment or life expectancy under 1 year
- Untreated alcohol or drug abuse
- Participating in another clinical trial or finished within 30 days
- Type 1 diabetes or diabetic ketoacidosis
- New York Heart Association (NYHA) class 4
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea, 03722
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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