Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation (EVENT)
Tricuspid Regurgitation, Heart Failure With Preserved Ejection Fraction
About this trial
This is an interventional treatment trial for Tricuspid Regurgitation
Eligibility Criteria
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
Sites / Locations
- Inha University Hospital
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- Seoul National University Hospital
- Yonsei University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Enavogliflozin
Placebo
Enavogliflozin 0.3 mg qd for 18 months
Placebo qd for 18 months