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Completed

NCT Number: NCT06964607

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Empagliflozin or Dapagliflozin

Conventional Treatment

Drug

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

Primary outcomes

  1. Assessment of clinical outcome

    Time frame: 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 outcomes

  1. Serum creatinine level

    Time frame: 6 months following revascularization

    Serum creatinine level was recorded.

  2. HbA1C level

    Time frame: 6 months following revascularization

    HbA1C level was recorded.

  3. NT-proBNP level

    Time frame: 6 months following revascularization

    NT-proBNP level was recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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