Acute ischaemic heart disease, unspecified. Acute ischemic heart disease, unspecified
Conditions
Interventions
Intervention 1: Intervention group: In the intervention group, participants will receive 10 milligrams of dapagliflozin once daily, administered orally, starting shortly after the diagnosis of acute c
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with type 2 diabetes who have recently experienced an acute coronary syndrome (ACS) and have a left ventricular ejection fraction (LVEF) in the range of 30–45% and are eligible to receive SGLT2 inhibitor therapy will be included. Additionally, these patients must have confirmed left atrial dysfunction based on echocardiographic evaluation, as assessed by specialist physicians during the initial examination. Blood pressure will be monitored before and after treatment due to its potential impact on study outcomes.
Exclusion criteria
Exclusion criteria: Additionally, all patients in the three groups will receive similar background medical treatments to eliminate the potential confounding effects of these therapies on the studied outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Left Atrial Volume (LAV) is one of the primary outcome variables in this study. It will be measured using two-dimensional echocardiography based on the area–length method. Left atrial areas from the two- and four-chamber views will be obtained, and LAV will be calculated using the formula: LAV = (0.85 × A1 × A2)/L. This parameter reflects structural changes in the left atrium in response to the intervention (dapagliflozin) and serves as a primary indicator of treatment efficacy. Timepoint: The primary outcome variable (left atrial volume) will be measured at two time points: 1.At baseline (before the initiation of the intervention) 2. Six months after the start of the intervention Echocardiographic assessment will be performed at both time points. Method of measurement: The primary outcome variable (left atrial volume) will be measured using a two-dimensional echocardiography device. The volume will be calculated by a cardiologist using the area–length method, based on images obtained from the two-chamber and four-chamber views. The echocardiography machine used will be equipped with advanced capabilities for accurate structural cardiac assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in estimated glomerular filtration rate (eGFR) is considered one of the secondary outcome variables in this study. This parameter is used to evaluate the effect of dapagliflozin on kidney function in patients with type 2 diabetes following acute coronary syndrome. eGFR will be calculated based on serum creatinine levels using the standard CKD-EPI formula. Measurements will be performed at baseline and again six months after the intervention. Timepoint: The time points for measuring estimated glomerular filtration rate (eGFR) as a secondary outcome are:1. At baseline (before the start of the intervention) 2. Six months after the initiation of the intervention These time points are selected to assess changes in kidney function in response to dapagliflozin treatment. Method of measurement: The estimated glomerular filtration rate will be calculated using the standard Chronic Kidney Disease Epidemiology Collaboration formula based on serum creatinine levels. Blood samples will be collected by a laboratory technician, and serum creatinine will be analyzed using an automated laboratory biochemistry analyzer.The eGFR will then be calculated by the physician using the mentioned formula. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Javad Mohammad Taghizadeh
Ahvaz University of Medical Sciences
Outcome results
None listed