Dapagliflozin Impact on Acute Myocardial Infarction in Type 2 Diabetes
This study aims to evaluate the effects of Dapagliflozin treatment on acute myocardial infarction in individuals with type 2 diabetes.
Dapagliflozin 10mg/Tab
+ control group
Cardiovascular Diseases+15
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 2
Treatment Study
Summary
Study start date: May 8, 2023
Actual date on which the first participant was enrolled.This study focuses on a medication called Dapagliflozin, which belongs to a group of drugs known as SGLT-2 inhibitors. These drugs have shown promise in treating heart failure. However, their effects on myocardial infarction, a common condition leading to death, are not fully understood. The study aims to investigate how Dapagliflozin might impact the short-term recovery of patients who have experienced a heart attack, as compared to a placebo. The potential outcomes of this research could provide valuable insights into improving care for heart attack patients and addressing current treatment challenges. During the study, participants will receive either Dapagliflozin or a placebo. The study will measure changes in heart function, specifically the left ventricular ejection fraction, left ventricle end-systolic volume, and left ventricular end-diastolic volume. These measurements help evaluate the heart's pumping efficiency. The study also monitors major adverse cardiovascular events (MACEs), such as heart attacks, strokes, and cardiovascular deaths. Additionally, it assesses the occurrence of post-infarction angina and the development of new-onset heart failure during the study period. The results of these measurements will help determine the potential benefits and risks of Dapagliflozin for heart attack patients.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.143 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Diagnosed with acute MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al. 2019), disease onset within 7 days. 2. Previously diagnosed with type2 diabetes mellitus, newly diagnosed type2 diabetes according to ADA criteria or glucose intolerance. 3. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol. Exclusion Criteria: 1. Patients diagnosed with Type 1 Diabetes Mellitus. 2. Patients with renal dysfunction. (GFR\<90mmol/L). 3. Patients who have recently undergone immunosuppressive therapy. 4. Patients with a history of recurrent urinary tract infections. 5. Patients who are known to be allergic to SGLT-2 inhibitors. 6. Patients who are hemodynamically unstable. 7. Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization. 8. Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial. 9. Any other non cardiovascular diseases, such as active malignancy requiring treatment at the time of screening or with a life expectancy of fewer than two years based on the investigator´s clinical judgment. 10. Currently on treatment with a sodium-glucose co-transporter 2 inhibitor (SGLT2-inhibitor).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location