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NCT Number: NCT07169981

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

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 ([email protected]).

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Key information

About this study

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 [[email protected]].

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patients who did not undergo primary PCI, those treated medically or had thrombolysis
  • Non diabetic patient.
  • Diabetic patient already on SGLTi
  • STEMIs other than anterior.
  • NSTEMI patients.
  • Patients having valvular heart diseases.
  • Patients having renal impairment.
  • Patients with LV myopathies of non-ischemic origin.

Treatment and study plan

Empagliflozin 10 MG [Jardiance]

Drug

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.

empagliflozin (Jardiance) 25 mg

Drug

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.

Primary outcomes

  1. left ventricular remodeling

    Time frame: 6 months

    change of left ventricular volumes form baseline and after 6 months

  2. left ventricular systolic function

    Time frame: 6 months

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

  3. left ventricular Global Longitudinal Strain (GLS)

    Time frame: 6 months

    changes of GLS from baseline and after 6 months

Secondary outcomes

  1. Incidence of Major Adverse Cardiovascular Events (MACE)

    Time frame: 6 months

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

  2. Assessment of diastolic function

    Time frame: 6 months

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

  3. Left Atrial Strain

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: EMPA-DMMI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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