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The Effect of Early Administration of Empagliflozin on Left Atrial Functional Recovery in Patients with Type 2 Diabetes Mellitus Following Acute Coronary Syndrome

The Effect of Early Administration of Empagliflozin on Left Atrial Functional Recovery in Patients with Type 2 Diabetes Mellitus Following Acute Coronary Syndrome: A Randomized Double-Blind Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250302064896N5
Enrollment
50
Registered
2025-10-11
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome. Acute coronary microvascular dysfunction

Interventions

Intervention 1: Intervention group: Participants in this group will receive a once-daily oral dose of 10 milligrams of empagliflozin following the diagnosis of acute coronary syndrome. The medication
empagliflozin will be added to the standard regimen. Intervention 2: Control group: Participants in this group will receive standard care for type 2 diabetes mellitus and acute coronary syndrome witho

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients aged over 18 years with confirmed type 2 diabetes mellitus Patients admitted with a recent diagnosis of acute coronary syndrome (ACS) Left ventricular ejection fraction (LVEF) between 30% and 45% Confirmed left atrial dysfunction based on echocardiography Eligibility to receive SGLT2 inhibitors based on clinical judgment Hemodynamic stability after ACS diagnosis HbA1c equal to or greater than 6.5% or fasting plasma glucose over 126 mg/dL Written informed consent provided by the patient No prior treatment with SGLT2 inhibitors No history of drug intolerance to SGLT2 inhibitors

Exclusion criteria

Exclusion criteria: Estimated glomerular filtration rate (eGFR) less than 20 mL/min/1.73m2 History of recurrent urinary tract infections (UTIs) End-stage renal disease (ESRD) patients receiving dialysis Confirmed valvular heart disease Severe liver failure Advanced heart failure with NYHA class IV Current treatment with SGLT2 inhibitors Known intolerance or hypersensitivity to SGLT2 inhibitors Concurrent inflammatory diseases such as active infection, pyelonephritis, urosepsis, or sepsis Diabetic ketoacidosis (DKA) at the time of enrollment Refusal to participate or not signing informed consent form

Design outcomes

Primary

MeasureTime frame
Left Atrial Strain, as a functional parameter of the left atrium, measured using speckle-tracking echocardiography at baseline and after six months; includes reservoir strain, conduit strain, and booster pump strain, each assessed separately. Timepoint: Measurement of left atrial strain at the beginning of the study (prior to intervention) and at the end of week twenty-four (six months after the start of intervention). Method of measurement: Left atrial strain will be measured using speckle-tracking echocardiography with two-dimensional imaging from apical four-chamber and two-chamber views; images will be acquired with an advanced echocardiography device (GE Vivid E95) and analyzed using dedicated strain analysis software in a specialized core lab.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Javad Mohammad Taghizadeh

Ahvaz University of Medical Sciences

dr.taghizadeh87@gmail.com+98 61 3339 4810

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026