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CompletedNCT06964607Updated May 9, 2025

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

An observational study in Sodium-glucose Cotransporter 2, Inhibitors and Clinical Outcome, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-09.

Sponsored by Tanta University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Sodium-glucose Cotransporter 2
  • Inhibitors
  • Clinical Outcome
  • Left Ventricule
  • Acute Myocardial Infarction
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 80 is below the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DrugSodium-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).

    Also known as: Empagliflozin or Dapagliflozin

  • DrugConventional treatment

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

06

What researchers measure

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.

    Time frame: 6 months following revascularization

Secondary outcomes

  1. Serum creatinine level

    Serum creatinine level was recorded.

    Time frame: 6 months following revascularization

  2. HbA1C level

    HbA1C level was recorded.

    Time frame: 6 months following revascularization

  3. NT-proBNP level

    NT-proBNP level was recorded.

    Time frame: 6 months following revascularization

07

Study locations

1 site
  • Tanta University
    Tanta, El-Gharbia 31527, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06964607
Lead sponsor
Tanta University
Responsible party
Asmaa Atef Hussein Mohammed (Resident of Cardiovascular Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt., Tanta University) — Principal investigator
First posted
May 9, 2025
Start date
Apr 1, 2023
Primary completion
Apr 1, 2024
Completion
Apr 1, 2024
Last update
May 9, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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