Effects of Dapagliflozin, Semaglutide, and Their Combination in Heart Failure Patients With Prosthetic Heart Valves

What Was Tested

The trial (phase 2) is built around Semaglutide.

This study evaluates whether adding a medication called semaglutide to an existing treatment of dapagliflozin provides better outcomes for patients with heart failure who have previously undergone surgical heart valve replacement.

Dapagliflozin is already a standard treatment for managing heart failure symptoms.

However, many heart failure patients-especially those who have had surgical prosthetic valve replacements-continue to experience persistent symptoms, fluid retention, and a decline in their quality of life.

It had two arms (groups): Combination Therapy Arm (experimental) and Monotherapy Control Arm (active comparator).

The registry classes the interventions as drug.

More on the Plan

Key secondary and surrogate clinical outcomes assessed across the treatment duration include changes in New York Heart Association (NYHA) functional class, evaluation of fluid retention and diuretic requirements, echocardiographic parameters evaluating cardiac structure and function, and standardized quality-of-life assessment scores.

Safety and tolerability profiles-including adverse event rates and systemic hemodynamic responses-will be rigorously monitored across both treatment cohorts.

Who Took Part

The registry lists 160 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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 willing and able to provide written informed consent prior to any study-related procedures.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: known hypersensitivity or allergy to semaglutide, dapagliflozin, or any of their excipients; type 1 diabetes mellitus; active pregnancy, breastfeeding, or intent to become pregnant during the 12-week study period.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

The Semaglutide group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Semaglutide was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2025-06-02 with completion listed for 2026-04-29.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from Baseline in Left Ventricular Global Longitudinal Strain (LV-GLS) assessed by echocardiography (time frame: Baseline and 12 weeks).

It also tracked 4 secondary outcomes, for example Change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, Change from baseline in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), Change from baseline in Six-Minute Walk Test (6MWT) distance and Change from Baseline in E/e' Ratio assessed by echocardiography.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 160 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.