Investigating the heart-protective effects of early Dapagliflozin in heart attack patients

Clinical Investigation of Cardioprotective Effect of Early Administration of Sodium-glucose Cotransport-2 Inhibitors in Patients With Acute Myocardial Infarction

This study is testing if giving Dapagliflozin early to heart attack patients can help protect their hearts and reduce damage when they receive treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tanta University (Academic / other)
• Locations: 1 site (Shibīn al Kawm, Menofia)
• Trial ID: NCT06009874 on ClinicalTrials.gov

What this trial studies

This clinical investigation focuses on the early administration of Dapagliflozin (DAPA) in patients experiencing acute myocardial infarction (AMI) to assess its cardioprotective effects. The study aims to determine whether DAPA can reduce infarct size and mitigate myocardial damage related to reperfusion injury when given before percutaneous coronary intervention (pPCI). Participants will receive DAPA or a placebo, and their cardiac biomarkers will be monitored over a three-month follow-up period to evaluate the drug's effectiveness in preventing heart failure and acute kidney injury. The study is particularly relevant as DAPA has been approved for heart failure but lacks sufficient data on its impact in AMI cases.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with ST-elevation myocardial infarction (STEMI) who meet specific health criteria.

Not a fit: Patients with severe conditions such as cardiogenic shock, advanced cancer, or those with a history of diabetic ketoacidosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes for heart attack patients by reducing heart damage and preventing heart failure.

How similar studies have performed: While DAPA has shown promise in heart failure patients, this specific application in AMI is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Patients with ST-elevation myocardial infarction (STEMI).
2. STEMI was defined according to the Fourth Universal Definition of AMI.
3. 18 - 80 years of age.
4. Diabetics or non-diabetics.
5. eGFR \> 45 ml/min/1.73m2.
6. Blood pressure before first drug dosing \>110/70 mmHg.

Exclusion Criteria:

1. Cardiogenic shock.
2. Hypoglycemia.
3. History of diabetic ketoacidosis.
4. Genital and urinary infections.
5. History of AMI.
6. Stent thrombosis.
7. Previous coronary artery bypass surgery.
8. Severe hepatic insufficiency.
9. Advanced cancer patients.
10. Blood pH \< 7.32.
11. Known allergy to SGLT-2 inhibitors.
12. Hemodynamic instability.
13. Females of childbearing potential without adequate contraceptive methods.
14. Patients currently on or have received any SGLT-2 inhibitors.

Where this trial is running

Shibīn al Kawm, Menofia

• Mohammad Soliman — Shibīn al Kawm, Menofia, Egypt (Recruiting)

Study contacts

• Study coordinator: Mohammad Soliman

Conditions Myocardial Infarction