Clinical trial NCT06964607: Impact of Sodium Glucose Co-transporter 2-Inhibitors on Clinical Outcome and Left Ventricular Function in Patients Presented by Acute Myocardial Infarction
Official title: Impact of Sodium Glucose Co-transporter 2-Inhibitors on Clinical Outcome and Left Ventricular Function in Patients Presented by Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sodium-glucose Cotransporter 2
Inhibitors
Clinical Outcome
Left Ventricule
Acute Myocardial Infarction
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Primary outcomes:
measure: Assessment of clinical outcome
timeFrame: 6 months following revascularization
Secondary outcomes:
measure: Serum creatinine level
timeFrame: 6 months following revascularization
measure: HbA1C level
timeFrame: 6 months following revascularization
measure: NT-proBNP level
timeFrame: 6 months following revascularization
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: