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

Sponsor
Ain Shams University
Study ID
NCT07169981
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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 (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.

Study Details

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\[email protected]).

Key Dates

Start date
Jul 12, 2023
Status verified
Jul 2025
Primary completion
Feb 23, 2025
Completion
Jun 17, 2025

Study Design

Enrollment
200 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.
  • 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.

Primary Outcome Measure

left ventricular remodeling [ Time Frame: 6 months ]

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