KCT0008631尚未招募Unknown
Multicenter, randomized, double-blind, placebo-controlled study toassess the effects of enavogliflozin on outcomes in patients withfunctional tricuspid regurgitation and preserved left ventricularejection fraction
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 588
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
- 20(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1.Patients must agree to the study protocol and provide written informed consent
- •2. Outpatients male or female between the age of 20 and 80
- •3. Non-diabetic or type2 DM patients with HbA1c 6.5-10.5%
- •4. Dyspnea of NYHA functional class II or III5. Presence of moderate or severe functional TR and preserved LVEF on echocardiography performedfor evaluation of patients presented with HF symptoms
- •-TR whose vena contracta = 0.3cm, effective regurgitant orifice area = 0.20 cm2, or jet area >10cm2
- •- LVEF = 50%
排除标准
- •1. History of hypersensitivity or allergy to the study drugs, drugs of similar chemical classes, as well asknown or suspected contraindications to the study drug
- •2. Current use or prior use of a SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor
- •3. Any evidence of structural tricuspid valve disease
- •4. Any significant left-sided valve disease
- •5. Left ventricular ejection fraction <50%
- •6. Marked bradycardia or 2nd or 3rd degree AV block
- •7. Severe pulmonary hypertension: TR Vmax > 3.5m/s at screening
- •8. Medical history of hospitalization within 6 weeks
- •9. Current acute decompensated heart failure or dyspnea of NYHA functional class IV
- •10. Symptomatic hypotension and/or a SBP < 90 mmHg at screening
- •11. Estimated GFR < 30 mL/min/1.73m2
- •12. History of ketoacidosis
- •13. Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding2 x upper limit of normal (ULN) at screening visit (Visit 0), history of hepatic encephalopathy, historyof esophageal varices, or history of portocaval shunt.
- •14. Acute coronary syndrome, stroke, major CV surgery, PCI within 3 months
- •15. History of severe pulmonary disease
- •16. Women of child-bearing potential, defined as all women physiologically capable of becomingpregnant, unless they are using a barrier method plus a hormonal method
- •17. Pregnant or nursing (lactating) women
- •18. Any clinically significant abnormality identified at the screening visit, physical examination,laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safecompletion of the study
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