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Diabetes drug could help heart failure patients with leaky valve

NCT ID NCT06027307

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

541 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

20 to 80 years

Sex

Anyone

Healthy volunteers

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

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

  • Asan Medical Center

    Seoul, South Korea

  • Inha University Hospital

    Incheon, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Yonsei University Medical Center

    Seoul, South Korea

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