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

NCT ID: NCT06964607

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-04-01

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

Conditions

Sodium-glucose Cotransporter 2; Inhibitors; Clinical Outcome; Left Ventricule; Acute Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sodium-glucose cotransporter-2 Inhibitors group

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).

Sodium-glucose cotransporter-2 Inhibitors

Intervention Type: DRUG

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

Patients received conventional management of acute myocardial infarction and reperfusion therapy as indicated without adding sodium-glucose co-transporter-2 inhibitors.

Conventional treatment

Intervention Type: DRUG

Patients received conventional management of acute myocardial infarction and reperfusion therapy as indicated without adding sodium-glucose co-transporter-2 inhibitors.

Interventions

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).

Intervention Type: DRUG

Conventional treatment

Patients received conventional management of acute myocardial infarction and reperfusion therapy as indicated without adding sodium-glucose co-transporter-2 inhibitors.

Intervention Type: DRUG

Other Intervention Names

Empagliflozin or Dapagliflozin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa Atef Hussein Mohammed

Resident of Cardiovascular Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Countries

Egypt

Other Identifiers

36264MS145/4/23

Identifier Type: -

Identifier Source: org_study_id