ClinicalTrials.gg
CompletedNCT07169981EMPA-DMMIUpdated Sep 12, 2025

Effect of Empagliflozin 10 vs 25 mg on LV Remodeling in Diabetic Patients With Anterior STEMI With Reduced LVEF

A Phase 2 interventional study of Empagliflozin 10 MG [Jardiance] and empagliflozin (Jardiance) 25 mg in Diabete Mellitus, Heart Failure and Remodeling, Left Ventricle, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jul 2023, registered Aug 2025).
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is investigating how the medication Empagliflozin affects the heart's structure and function in patients with heart disease. Empagliflozin is already used to treat diabetes and heart conditions, and this research aims to see if it can help improve heart remodeling, which may lead to better heart health and quality of life. Participants will receive the medication and have regular check-ups to monitor their progress. The study is carefully designed to ensure participant safety. If you have heart disease and want to learn more, please contact (hany_barsoum@med.asu.edu.eg).

Read the detailed description

Heart disease is a leading cause of illness worldwide, and new treatments that improve heart function can have a significant impact on patient health and longevity. This research could provide valuable insights into how existing medications can be used to benefit people with heart conditions beyond their current use.

This clinical study aims to understand how Empagliflozin, a medication commonly used to treat diabetes, affects the heart's structure and function in people with heart disease. When the heart is damaged, especially on the left side (left ventricle), it can change shape and size-a process called remodeling-which may reduce how well the heart pumps blood. This study will explore whether Empagliflozin can help reverse or improve this remodeling process, potentially leading to better heart function and improved quality of life.

Participants in the study will receive Empagliflozin and undergo regular health check-ups, including imaging tests like echocardiograms, to track changes in heart structure and performance. The study is designed to carefully monitor safety and effectiveness, ensuring participants are supported throughout.

If you or a loved one has heart disease and are interested in learning more about this study, please contact [hany_barsoum@med.asu.edu.eg].

02

Conditions studied

  • Diabete Mellitus
  • Heart Failure
  • Remodeling, Left Ventricle

Keywords

  • Empagliflozin
  • Heart Failure
  • Left Ventricular Remodeling
  • Diabetes Mellitus
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's enrollment of 200 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Diabetic patients with anterior STEMI with reduced who underwent PPCI with successful revascularization and resulting into TIMI III flow and who are receiving SGLTi for the first time.

Exclusion criteria

Exclusion Criteria:

  1. patients who did not undergo primary PCI, those treated medically or had thrombolysis
  2. Non diabetic patient.
  3. Diabetic patient already on SGLTi
  4. STEMIs other than anterior.
  5. NSTEMI patients.
  6. Patients having valvular heart diseases.
  7. Patients having renal impairment.
  8. Patients with LV myopathies of non-ischemic origin.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Empagliflozin 10 mg

    Participants in this arm will receive Empagliflozin 10 mg orally once daily for a duration of 6 months. The purpose is to evaluate the effect of Empagliflozin on left ventricular remodeling and cardiac function in patients with HFrEF. Standard heart failure therapy may be continued alongside the study drug as clinically indicated.

    Drug: Empagliflozin 10 MG [Jardiance]

  • Experimental
    Empagliflozin 25 mg

    Participants in this arm will receive Empagliflozin 25 mg orally once daily for a duration of 6 months. The purpose is to evaluate the effect of Empagliflozin on left ventricular remodeling and cardiac function in patients with HFrEF. Standard heart failure therapy may be continued alongside the study drug as clinically indicated.

    Drug: empagliflozin (Jardiance) 25 mg

Interventions

  • This intervention consists of Empagliflozin 10 mg oral tablets administered once daily for a duration of 6 months. The drug is used in this study to evaluate its effect on left ventricular remodeling in patients with heart failure. Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor approved for the treatment of type 2 diabetes and heart failure. In this trial, it is being investigated specifically for its impact on cardiac structure and function.

  • This intervention consists of Empagliflozin 25 mg oral tablets administered once daily for a duration of 6 months. The drug is used in this study to evaluate its effect on left ventricular remodeling in patients with heart failure. Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor approved for the treatment of type 2 diabetes and heart failure. In this trial, it is being investigated specifically for its impact on cardiac structure and function.

06

What researchers measure

Primary outcomes

  1. left ventricular remodeling

    change of left ventricular volumes form baseline and after 6 months

    Time frame: 6 months

  2. left ventricular systolic function

    change of left ventricular ejection fraction from baseline and after 6 months

    Time frame: 6 months

  3. left ventricular Global Longitudinal Strain (GLS)

    changes of GLS from baseline and after 6 months

    Time frame: 6 months

Secondary outcomes

  1. Incidence of Major Adverse Cardiovascular Events (MACE)

    MACE is defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.

    Time frame: 6 months

  2. Assessment of diastolic function

    studying the effect of different doses of Empagliflozin not only on systolic function but also on diastolic function with E/E'

    Time frame: 6 months

  3. Left Atrial Strain

    studying the effect of different doses of Empagliflozin on Left Atrial Strain

    Time frame: 6 months

07

Study locations

1 site
  • Ain Shams University Hospitals
    Cairo, Egypt
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07169981
Responsible party
Sponsor
First posted
Sep 12, 2025
Start date
Jul 12, 2023
Primary completion
Feb 23, 2025
Completion
Jun 17, 2025
Last update
Sep 12, 2025

Study contacts

Zainab A. Fahmy, Professor of Cardiology
study chair · Ain Shams University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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