Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation

Inclusion Criteria: * Patients must agree to the study protocol and provide written informed consent * Outpatients male or female between the age of 20 and 80 * Non-diabetic or type2 DM patients with HbA1c 6.5-10.5% * HF with dyspnea of NYHA functional class II or III * Presence of moderate or severe functional TR and preserved LVEF on echocardiography * TR whose vena contracta ≥ 0.3cm, effective regurgitant orifice area ≥ 0.20 cm2, or jet area \> 10cm2 * LVEF ≥ 50% * NT-proBNP \>125 pg/mL or BNP ≥35 pg/mL Exclusion Criteria: * History of hypersensitivity or allergy to the study drugs, drugs of similar chemical classes, as well as known or suspected contraindications to the study drug * Current use or prior use of a SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor * Any evidence of structural tricuspid valve disease * Any significant left-sided valve disease * Left ventricular ejection fraction \<50% * Marked bradycardia or 2nd or 3rd degree AV block * Intracardiac devices (CRT, ICD, Pacemaker) * Hypertrophic or restrictive cardiomyopathy * Severe pulmonary hypertension: TR Vmax \> 3.5m/s at screening * Medical history of hospitalization within 4 weeks * Current acute decompensated heart failure or dyspnea of NYHA functional class IV * Symptomatic hypotension and/or a SBP \< 90 mmHg at screening * Uncontrolled hypertension (SBP≥180mmHg or DBP≥110mmHg) * Estimated GFR \< 30 mL/min/1.73m2 * History of ketoacidosis * Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 2 x upper limit of normal (ULN) at screening visit (Visit 0), history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt. * Acute coronary syndrome, stroke, major CV surgery, PCI within 3 months * Plan for cardiac surgery, PCI or ablation of atrial flutter of fibrillation * History of severe pulmonary disease * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using a barrier method plus a hormonal method * Pregnant or nursing (lactating) women * Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study