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

NCT ID: NCT07169981

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-12
• Study Completion Date: 2025-06-17

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).

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].

Conditions

Diabete Mellitus; Heart Failure; Remodeling, Left Ventricle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Empagliflozin 10 MG [Jardiance]

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

empagliflozin (Jardiance) 25 mg

Intervention Type: 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.

Interventions

Empagliflozin 10 MG [Jardiance]

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.

Intervention Type: DRUG

empagliflozin (Jardiance) 25 mg

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.

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zainab A. Fahmy, Professor of Cardiology

Role: STUDY_CHAIR

Ain Shams University

Locations

Ain Shams University Hospitals

Cairo, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

FMASU MD 100/2023

Identifier Type: -

Identifier Source: org_study_id