The Effect of Dapagliflozin on the Short-term Prognosis of Patients With Acute Myocardial Infarction

Launched by QINGDAO CENTRAL HOSPITAL · Sep 9, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called dapagliflozin on patients who have recently experienced a heart attack, known medically as acute myocardial infarction (MI). Dapagliflozin is part of a group of medicines called SGLT-2 inhibitors, which have shown promise in improving heart health. The goal of this trial is to see if dapagliflozin can help improve the short-term recovery and overall health of patients after a heart attack compared to a placebo, which is a dummy treatment with no active medication.

To qualify for the study, participants must have had a heart attack within the last week and have a diagnosis of type 2 diabetes or glucose intolerance. They should also be able to give informed consent, meaning they understand the study and agree to participate. However, individuals with certain conditions, like type 1 diabetes, severe kidney issues, or recent treatment that weakens the immune system, won't be eligible. If you join the trial, you'll be monitored closely to see how well the medication works and whether it helps improve your health after a heart attack. This study is important because it aims to find new ways to support recovery for patients facing serious heart conditions.

Gender

ALL

Eligibility 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).