Enavogliflozin for treating heart failure with 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
This study is testing if a new heart medication called enavogliflozin can help people with heart failure and tricuspid regurgitation feel better and improve their heart function over 18 months.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 540 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 5 sites (Incheon and 4 other locations) |
| Trial ID | NCT06027307 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of enavogliflozin, an SGLT2 inhibitor, on patients with heart failure and functional tricuspid regurgitation. It aims to determine if enavogliflozin can improve clinical outcomes and echocardiographic measures compared to a placebo over 18 months. The study will also assess the drug's impact on renal events and all-cause mortality. Participants will be closely monitored for cardiovascular events and changes in tricuspid regurgitation severity.
Who should consider this trial
Good fit: Ideal candidates are outpatients aged 20 to 80 with heart failure symptoms, moderate to severe functional tricuspid regurgitation, and preserved left ventricular ejection fraction.
Not a fit: Patients with structural tricuspid valve disease or significant left-sided valve disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart failure management and outcomes for patients with functional tricuspid regurgitation.
How similar studies have performed: While there have been no proven medical therapies for tricuspid regurgitation, the use of SGLT2 inhibitors has shown promise in other heart failure contexts, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Incheon and 4 other locations
- Inha University Hospital — Incheon, Korea, Republic of (Not_yet_recruiting)
- Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
- Seoul National University Hospital — Seoul, Korea, Republic of (Not_yet_recruiting)
- Yonsei University Medical Center — Seoul, Korea, Republic of (Not_yet_recruiting)
Study contacts
- Principal investigator: Duk Hyun Kang, Md — Asan Medical Center
- Study coordinator: Duk Hyun Kang, Md
- Email: dhkang@amc.seoul.kr
- Phone: 82-2-3010-3166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.