Diabetes drug could help heart failure patients with leaky valve
NCT ID NCT06027307
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether enavogliflozin, a diabetes drug, can improve outcomes in people with heart failure and a leaky tricuspid valve. About 541 participants will receive either the drug or a placebo for 18 months. Researchers will track heart-related events, valve worsening, and kidney function to see if the drug helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Enavogliflozin (a diabetes drug that helps the heart and kidneys)
- What this could lead to
- If it works, this could offer a new treatment option for heart failure patients with a leaky tricuspid valve, potentially reducing hospitalizations and improving survival.
- What could go wrong
- This is a single phase 3 trial with 541 participants, so results may not apply to all patients. The drug may not show significant benefit over placebo, and side effects like dehydration or kidney issues are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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541 people
The number who actually took part.
- Started
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Oct 2023
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Asan Medical Center
Seoul, South Korea
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Inha University Hospital
Incheon, South Korea
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Samsung Medical Center
Seoul, South Korea
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Seoul National University Hospital
Seoul, South Korea
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Yonsei University Medical Center
Seoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a daily pill shield hearts in HFpEF?
- Lung and liver scans could map hidden heart valve disease
- Jugular vein approach tested for replacing leaky heart valve without open surgery
- Implanted device aims to ease heart failure symptoms
- Can a once-daily pill ease the burden of a common heart failure?