KCT0009434尚未招募Unknown
ENavogliflozin DElivering Alleviation of Ventricular diastolic dysfunction in nonObstRuctive Hypertrophic CardioMyopathy: a prospective, multicenter, randomized, double-blind, placebo-controlled study (ENDEAVOR-HCM)
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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