Impact of Sodium Glucose Co-transporter 2-Inhibitors on Clinical Outcome and Left Ventricular Function in Patients Presented by Acute Myocardial Infarction

Completed

• Conditions: Sodium-glucose Cotransporter 2; Inhibitors; Clinical Outcome; Left Ventricule; Acute Myocardial Infarction
• Interventions: Drug: Sodium-glucose cotransporter-2 Inhibitors; Drug: Conventional treatment

• Registration Number: NCT06964607
• Lead Sponsor: Tanta University

Brief Summary

This study aimed to assess the effect of adding sodium glucose co-transporter two inhibitors on clinical outcome and left ventricular function in patients with acute myocardial Infarction.

Detailed Description

Sodium-glucose co-transporter-2 (SGLT-2) inhibitors are a class of anti-hyperglycemic agents that act on the SGLT-2 proteins expressed in the renal proximal convoluted tubules. They exert their effect by preventing the reabsorption of filtered glucose from the tubular lumen.

Early initiation and continuation of SGLT2 inhibition for acute myocardial infarction is appealing with many proposed mechanistic effects that may alter the natural history, predisposition to ventricular remodeling, and progression to chronic heart failure and end-stage heart disease

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01
• Study First Submitted: 2025-04-19
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-09
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

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

Inclusion Criteria

• Age ≥ 18 years.
• Both sexes.
• Recent myocardial infarction.

Evidence of significant myocardial necrosis defined as a rise in troponin level > 99th Percentile ULN (upper limit of normal). In addition, at least one of the following criteria must be met:

• Symptoms of ischemia.

• ECG changes indicative of new ischemia (new ST-T changes or new Left bundle branch block (LBBB))

• Imaging evidence of new regional wall motion abnormality.

  • Estimated Glomerular Filtration Rate (eGFR)> 30 ml/min/1.73 m2.
  • Blood pressure before first drug dosing >110/70 mmHg.

Exclusion Criteria

• Known allergy to sodium/glucose cotransporter 2 (SGLT2) inhibitors.
• Patients with poor echocardiographic views.
• Hemodynamic instability as defined by intravenous administration of catecholamine.
• >1 episode of severe hypoglycemia within the last 6 months under treatment with insulin or sulfonylurea.
• Pregnant women or females of childbearing age without adequate contraceptive methods.
• Acute symptomatic urinary tract infection (UTI) or genital infection
• Patients currently being treated with any SGLT-2 inhibitor or having received treatment with any SGLT-2 inhibitor within the 4 weeks before the screening visit.
• Patient with a previous myocardial ischemic event or previous heart failure.
• Patients with significant valvular dysfunction.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sodium-glucose cotransporter-2 Inhibitors group	Sodium-glucose cotransporter-2 Inhibitors	Patients received conventional management of acute myocardial infarction and reperfusion therapy as indicated, plus one of the available sodium-glucose co-transporter-2 Inhibitors in Egypt (Empagliflozin or Dapagliflozin), irrespective of the presence or absence of diabetes mellitus or type of heart failure(HFrEF, HFmEF, HFpEF).
Conventional treatment group	Conventional treatment	Patients received conventional management of acute myocardial infarction and reperfusion therapy as indicated without adding sodium-glucose co-transporter-2 inhibitors.

Primary Outcome Measures

Name	Time	Method
Assessment of clinical outcome	6 months following revascularization	Clinical outcome was studied at 6 months with notification of any adverse clinical events (ACE) during this period: Patients were followed-up for 6 months with documentation of any ACE including new ischemic event, worsening heart failure symptoms, arrhythmia, re-hospitalization or death, that developed during this period then re-classified into a group that did not develop any adverse clinical events and the other that showed ≥ one adverse clinical events to study the impact of different parameters on the incidence of ACE.

Secondary Outcome Measures

Name	Time	Method
Serum creatinine level	6 months following revascularization	Serum creatinine level was recorded.
HbA1C level	6 months following revascularization	HbA1C level was recorded.
NT-proBNP level	6 months following revascularization	NT-proBNP level was recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt