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Heart failure drug combo may improve valve function

NCT ID NCT07379788

Disease control Sponsor: Rehab Werida Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed study in 180 heart failure patients compared the effects of taking Entresto alone versus Entresto plus a second drug (empagliflozin) on mitral valve function and heart pumping ability. Participants had heart failure with reduced ejection fraction and some degree of functional mitral regurgitation. The study measured changes in heart structure and function using echocardiography.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sacubitril/Valsartan (Entresto) and Empagliflozin
What this could lead to
If successful, this could show that adding an SGLT2 inhibitor to standard ARNI therapy improves heart valve function and heart pumping ability in people with heart failure.
What could go wrong
This is a small, completed study with no phase designation, so results may not be definitive or widely applicable. The outcomes are imaging-based measures, not long-term clinical benefits like survival or hospitalizations.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

180 people

The number who actually took part.

Started

Jan 2025

Finished

Mar 2026

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

18 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: * age ≥18 years; * left ventricular ejection fraction (LVEF) \<50%; * Presence of functional mitral regurgitation (mild, moderate, or severe) on transthoracic echocardiography; and * stable sinus rhythm or controlled atrial fibrillation. Exclusion Criteria: * primary (degenerative or rheumatic) mitral valve disease, * prior mitral valve surgery or transcatheter intervention, * acute decompensated heart failure within four weeks, * significant primary valvular disease other than FMR, * severe renal impairment (estimated glomerular filtration rate \<30 mL/min/1.73 m²), * inadequate echocardiographic image quality.

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Conditions

The condition(s) this trial relates to.

heart failure mitral valve insufficiency systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

Contacts and locations

Locations

  • Madinah Cardiac Center

    Madinah, Saudi Arabia

More trials for these conditions

Other studies related to the condition(s) this trial covers.