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

NCT07169981 | Completed Phase 2

• 1 other identifier: FMASU MD 100/2023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabete Mellitus; Heart Failure; Remodeling, Left Ventricle

Keywords

Empagliflozin; Heart Failure; Left Ventricular Remodeling; Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• left ventricular remodeling

  change of left ventricular volumes form baseline and after 6 months

  6 months

• left ventricular systolic function

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

  6 months

• left ventricular Global Longitudinal Strain (GLS)

  changes of GLS from baseline and after 6 months

  6 months

Secondary Outcomes (3)

• Incidence of Major Adverse Cardiovascular Events (MACE)

  6 months

• Assessment of diastolic function

  6 months

• Left Atrial Strain

  6 months

Study Arms (2)

Empagliflozin 10 mg

EXPERIMENTAL

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]

Empagliflozin 25 mg

EXPERIMENTAL

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

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 10 mg

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.

Empagliflozin 25 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus; Heart Failure; Ventricular Remodeling

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Zainab A. Fahmy, Professor of Cardiology

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 12, 2025
• Study Start: July 12, 2023
• Primary Completion: February 23, 2025
• Study Completion: June 17, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)