Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation

Launched by ASAN MEDICAL CENTER · Aug 31, 2023

Keywords

ClinConnect Summary

The Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation (EVENT) is a research study that is looking at a new medication called enavogliflozin to see if it can help patients with heart failure who also have a condition called functional tricuspid regurgitation (TR). TR happens when the heart's tricuspid valve doesn’t close properly, which can lead to blood flowing backward into the heart. The study will compare the effects of enavogliflozin to a placebo (a fake treatment) over 18 months to see if it can improve heart health and reduce heart-related problems for patients with preserved left ventricular ejection fraction (LVEF), meaning their heart pumps well enough.

To be eligible for this study, participants should be between 20 and 80 years old and have certain conditions, such as moderate to severe functional TR and heart failure that causes shortness of breath. They should not have diabetes or serious heart valve problems, and they must be stable enough not to have been hospitalized recently. Participants will need to agree to follow the study guidelines and be willing to take the medication daily. Throughout the study, researchers will monitor their heart health and any side effects to see how well the treatment works. This trial is currently recruiting participants, and it aims to provide valuable information on the effectiveness of enavogliflozin for improving heart health in these patients.

Gender

ALL

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