NCT06027307Active, not recruitingPhase 3
Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Enavogliflozin on Outcomes in Patients With Functional Tricuspid Regurgitation and Heart Failure With Preserved Left Ventricular Ejection Fraction
Source: ClinicalTrials.gov · Last updated 29 Dec 2025
Brief summary (registry, in English)
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 improve clinical and echocardiographic outcomes in heart failure (HF) patients with functional tricuspid regurgitation (TR) and preserved left ventricular ejection fraction (LVEF). The primary objective of the EVENT study is to test the hypothesis that, compared with placebo, therapy with enavogliflozin for 18 months would improve a composite of cardiovascular events or worsening of TR on follow-up echocardiography in HF patients with functional TR and preserved LVEF. The secondary objective is to examine whether enavogliflozin is effective in reduction of renal events and tricuspid regurgitation, and to evaluate whether beneficial effects of enavogliflozin on primary outcomes are associated with reduction of all-cause mortality.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 541 (actual)
- First submitted
- 31 Aug 2023
- Start date
- 25 Oct 2023
- Primary completion date
- Jun 2027
- Lead sponsor
- Asan Medical Center
- Diseases
- Heart failure
- NCT number
- NCT06027307
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 541
- From 25 Oct 2023 to the primary completion date, Jun 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use or prior use of a SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor
Other illness
- 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
- Any evidence of structural tricuspid valve disease
- Any significant left-sided valve disease
- 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
- Uncontrolled hypertension (SBP≥180mmHg or DBP≥110mmHg)
- History of ketoacidosis
- 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
Lab values
- Left ventricular ejection fraction \<50%
- Estimated GFR \< 30 mL/min/1.73m2
- 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.
- 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
Other
- Marked bradycardia or 2nd or 3rd degree AV block
- Intracardiac devices (CRT, ICD, Pacemaker)
- Hypertrophic or restrictive cardiomyopathy
- Symptomatic hypotension and/or a SBP \< 90 mmHg at screening
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inha University Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Yonsei University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.