Status:
ACTIVE_NOT_RECRUITING
Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Tricuspid Regurgitation
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
The Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation (EVENT) was designed to examine the hypothesis that, compared with placebo, therapy with the SGLT2 inhibitor enavogliflozin would...
Detailed Description
Functional tricuspid regurgitation (TR) develops due to functional and structural alterations related to heart failure (HF), mitral valve disease and atrial fibrillation. An increase in cardiac fillin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2027
Estimated Enrollment :
541 Patients enrolled
Trial Details
Trial ID
NCT06027307
Start Date
October 25 2023
End Date
August 1 2027
Last Update
December 29 2025
Active Locations (5)
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1
Inha University Hospital
Incheon, South Korea
2
Asan Medical Center
Seoul, South Korea
3
Samsung Medical Center
Seoul, South Korea
4
Seoul National University Hospital
Seoul, South Korea