Sodium-glucose Cotransporter 2NCT06964607
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 of Sodium-glucose Cotransporter 2 and Inhibitors, run by Tanta University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sodium-glucose Cotransporter 2, Inhibitors, Clinical Outcome
- What is being tested?
- Sodium-glucose cotransporter-2 Inhibitors and Conventional treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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))
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Sodium-glucose Cotransporter 2, Inhibitors, Clinical Outcome, Left Ventricule, Acute Myocardial Infarction
- Being tested
- Sodium-glucose cotransporter-2 Inhibitors, Conventional treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium-glucose cotransporter-2 InhibitorsDrug
Also called Empagliflozin or Dapagliflozin
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 treatmentDrug
Patients received conventional management of acute myocardial infarction and reperfusion therapy as indicated without adding sodium-glucose co-transporter-2 inhibitors.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months following revascularization
Secondary outcomes (3)
Serum creatinine level
Serum creatinine level was recorded.
Measured: 6 months following revascularization
HbA1C level
HbA1C level was recorded.
Measured: 6 months following revascularization
NT-proBNP level
NT-proBNP level was recorded.
Measured: 6 months following revascularization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Apr 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sodium-glucose Cotransporter 2Studies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Atef Hussein Mohammed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964607
- Sponsor's protocol ID
- 36264MS145/4/23
- Status last verified
- May 2025
- First submitted
- 19 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sodium Glucose Co-transporter 2-Inhibitors on Clinical Outcome and Left Ventricular Function in Patients Presented by Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06964607
- Acronym / sponsor ID
- 36264MS145/4/23
- Conditions
- Sodium-glucose Cotransporter 2, Inhibitors, Clinical Outcome, Left Ventricule, Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium-glucose cotransporter-2 Inhibitors group | – | Drug: Sodium-glucose cotransporter-2 InhibitorsPatients 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 | – | Drug: Conventional treatmentPatients received conventional management of acute myocardial infarction and reperfusion therapy as indicated without adding sodium-glucose co-transporter-2 inhibitors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium-glucose cotransporter-2 InhibitorsAlso: Empagliflozin or DapagliflozinPatients 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 group |
| Conventional treatmentPatients received conventional management of acute myocardial infarction and reperfusion therapy as indicated without adding sodium-glucose co-transporter-2 inhibitors. | Drug | Conventional treatment group |
Primary outcome
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.
3 secondary outcomes
Serum creatinine level
Time frame: 6 months following revascularization
HbA1C level
Time frame: 6 months following revascularization
NT-proBNP level
Time frame: 6 months following revascularization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sodium-glucose Cotransporter 2 and Inhibitors, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of clinical outcome (time frame: 6 months following revascularization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.