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Could a diabetes drug help heart failure patients with valve replacements?

NCT ID NCT07610174

Disease control Sponsor: Kafrelsheikh University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looked at whether adding semaglutide (a drug used for diabetes and weight loss) to the standard heart failure medication dapagliflozin helps people with heart failure who have had a surgical heart valve replacement. 160 participants were split into two groups: one got the combination therapy, the other continued dapagliflozin alone. Researchers tracked changes in heart function, symptoms, and quality of life to see if the combo offers extra benefits.

What this could mean

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

Active substance
semaglutide
What this could lead to
If it works, this could point toward a new combination treatment to improve heart function and quality of life for heart failure patients with valve replacements.
What could go wrong
This is a small, early-phase proof-of-concept trial, so results may not be definitive. The combination may not provide additional benefit over standard care and could cause side effects like nausea or gastrointestinal issues.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

160 people

The number who actually took part.

Started

Jun 2025

Finished

Apr 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 years and older

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 is at least 18 years at the time of screening. * Confirmed diagnosis of heart failure. * Documented history of surgical prosthetic heart valve replacement. * Patient is currently on a stable baseline regimen of dapagliflozin (10 mg once daily). * Patient is willing and able to provide written informed consent prior to any study-related procedures. Exclusion Criteria: * Known hypersensitivity or allergy to semaglutide, dapagliflozin, or any of their excipients. * Type 1 diabetes mellitus. * Severe renal impairment (e.g., eGFR \< 25 or 30 mL/min/1.73m², depending on your exact protocol threshold) or currently requiring dialysis. * Active pregnancy, breastfeeding, or intent to become pregnant during the 12-week study period. * Participation in another conflicting interventional clinical trial within the past 30 days.

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

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

Heart failure Heart valve prosthesis

Contacts and locations

Locations

  • Kafrelsheikh univeristy hospital, Faculty of medicine, Kafrelsheikh univeristy

    Kafr ash Shaykh, Kafrelsheikh Governrate, 33511, Egypt

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