Multicenter, randomized, double-blind, placebo-controlled study toassess the effects of enavogliflozin on outcomes in patients withfunctional tricuspid regurgitation and preserved left ventricularejection fractio
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0008631
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 588
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%
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method aboratory test, EKG, Chest PA, Echocardiography
- Secondary Outcome Measures
Name Time Method aboratory test, EKG, Chest PA, Echocardiography