Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation
South Korea541 participantsStarted 2023-10-25
Plain-language 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 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.
Who can participate
Age range
20 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 on…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.