Clinical Investigation of the Cardioprotective Effect of Early Administration of SGLT2 in Patients Presented With AMI

Not Applicable

Recruiting

• Conditions: Myocardial Infarction
• Interventions: Drug: Placebo; Drug: Dapagliflozin 10mg Tab

• Registration Number: NCT06009874
• Lead Sponsor: Mohammad Hussien Tantawy Soliman

Brief Summary

This study aims to investigate the effect of early administration of DAPA during ischemia and before pPCI on infarct size, reperfusion injury-related myocardial damage, cardioprotection from HF, and renoprotection from AKI in patients with AMI.

Detailed Description

DAPA was approved for HF patients, but there is no sufficient data about its efficacy on patients with AMI and if it can protect from the development of HF after AMI.

the investigators aim to investigate the effect of DAPA on patients who presented with AMI when administered as early as possible before pPCI and to be continued for three months after there.

the effect of DAPA on infarct size, cardiac biomarkers will be assessed during the follow-up period

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-11
• Study First Submitted QC: 2023-08-18
• Last Update Submitted: 2023-08-18
• Study First Posted: 2023-08-24
• Last Update Posted: 2023-08-24
• Study Start: 2023-10
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	patients with MI will be treated with a matching placebo once daily for three months.
Dapagliflozin group	Dapagliflozin 10mg Tab	patients with MI will be treated with DAPA 10 mg once daily for three months.

Primary Outcome Measures

Name	Time	Method
difference in NT-proBNP level	3 months	NT-proBNP level (pg/ml) for both groups
difference in infarct size	3 months	infarct size measurement (percentage) for both groups

Secondary Outcome Measures

Name	Time	Method
Difference in eGFR	3 months	Decline in eGFR (ml/min) for both groups

Trial Locations

Locations (1)

Mohammad Soliman; 🇪🇬 Shibīn Al Kawm, Menofia, Egypt