None listed
Conditions
Interventions
Drug : 588 patients will be randomized in a 1:1 ratio to two arms:a(Enavogliflozinb) Placebo All study patients will receive enavogliflozin or placebo in addition to their usual medications.
Inpatien
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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%
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| aboratory test, EKG, Chest PA, Echocardiography | — |
Secondary
| Measure | Time frame |
|---|---|
| aboratory test, EKG, Chest PA, Echocardiography | — |
Countries
Korea, Republic of
Contacts
Public ContactDukhyun Kang
Asan Medical Center
Outcome results
None listed