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

NCT06964607 | Completed

• 1 other identifier: 36264MS145/4/23
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Assessment of clinical outcome

  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.

  6 months following revascularization

Secondary Outcomes (3)

• Serum creatinine level

  6 months following revascularization

• HbA1C level

  6 months following revascularization

• NT-proBNP level

  6 months following revascularization

Study Arms (2)

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).

Drug: Sodium-glucose cotransporter-2 Inhibitors

Conventional treatment group

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

Drug: Conventional treatment

Interventions

Sodium-glucose cotransporter-2 Inhibitors 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).

Also known as: Empagliflozin or Dapagliflozin

Sodium-glucose cotransporter-2 Inhibitors group

Conventional treatment DRUG

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

Conventional treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a prospective, non-randomized study had been conducted on 80 patients with newly diagnosed acute myocardial infarction presented to cardiovascular medicine department, Tanta university hospital between April 2023 and April 2024.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

empagliflozin; dapagliflozin

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Cardiovascular Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: May 9, 2025
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)