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IRCT20250302064896N1 IRCT 2025-04-17 Ahvaz University of Medical Sciences Effect of Early Use of Dapagliflozin on Improvement of Left Atrial Function in Patients with Type 2 Diabetes after Acute Coronary Syndrome Evaluation of the Early Use of Dapagliflozin on the Improvement of Left Atrial Function in Type 2 Diabetic Patients Following Acute Coronary Syndrome 2025-04-19 anticipated 55 Complete https://irct.ir/trial/82829 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization process in this study was performed using a specialized randomization website that generates random allocation sequences based on blocks of 4 and 8. Participants were randomly assigned to either the dapagliflozin group or the control group without any investigator involvement in the allocation process. A unique random code was generated for each participant and securely recorded in the system to ensure allocation concealment and prevent selection bias. The allocation codes were placed in sealed envelopes containing the intervention details and opened by an independent individual not involved in the study. This method guarantees proper randomization and complete allocation concealment, Blinding description: In the design of this study, it is anticipated that participants and the treatment team (including physicians and nurses) will be blinded to group allocation. The allocation process is planned to be conducted using confidential random codes by an independent individual. Additionally, the medications will be provided in identical packaging to prevent identification of the groups. Accordingly, the study is expected to be conducted as a double-blind trial to minimize the risk of bias in the results. 3 Acute ischaemic heart disease, unspecified. 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 coronary syndrome and hospital admission. The treatment will continue for a duration of six months. All other standard treatments for diabetes and cardiovascular disease will be kept consistent between both groups to isolate the effect of dapagliflozin on the study outcomes. Intervention 2: Control group: Control group: Participants in this group will receive standard treatment for type 2 diabetes and cardiovascular disease. This includes the use of medications such as metformin and other approved drugs for blood glucose management, blood pressure control, and lipid regulation. Sodium-glucose co-transporter 2 (SGLT2) inhibitors, including dapagliflozin, will not be included in the treatment regimen of this group. Other concomitant medications will be kept similar to the intervention group to ensure that the isolated effect of dapagliflozin can be accurately assessed. No - There is not a plan to make this available Justification or reason for not sharing IPD is No additional information is available.
public Mohammad Javad Mohammad Taghizadeh
Golestan Highway
Ahvaz Iran (Islamic Republic of) 6139853711 +98 61 3339 4810 dr.taghizadeh87@gmail.com Ahvaz University of Medical Sciences scientific Mohammad Javad Mohammad Taghizadeh
Golestan Highway
Ahvaz Iran (Islamic Republic of) 6139853711 +98 61 3339 4810 dr.taghizadeh87@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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. 18 years no limit Both 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. I24.9 Acute ischemic heart disease, unspecified Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, participants will receive 10 milligrams of dapagliflozin once daily, administered orally, starting shortly after the diagnosis of acute coronary syndrome and hospital admission. The treatment will continue for a duration of six months. All other standard treatments for diabetes and cardiovascular disease will be kept consistent between both groups to isolate the effect of dapagliflozin on the study outcomes. Control group: Control group: Participants in this group will receive standard treatment for type 2 diabetes and cardiovascular disease. This includes the use of medications such as metformin and other approved drugs for blood glucose management, blood pressure control, and lipid regulation. Sodium-glucose co-transporter 2 (SGLT2) inhibitors, including dapagliflozin, will not be included in the treatment regimen of this group. Other concomitant medications will be kept similar to the intervention group to ensure that the isolated effect of dapagliflozin can be accurately assessed. 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. 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. Ahvaz Jundishapur University of Medical Sciences (AJUMS) Approved 2025-02-15 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences (AJUMS) Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)