Diabete MellitusPhase 2EMPA-DMMINCT07169981
Effect of Empagliflozin 10 vs 25 mg on LV Remodeling in Diabetic Patients With Anterior STEMI With Reduced LVEF
A Phase 2 study testing Empagliflozin 10 MG [Jardiance] and empagliflozin (Jardiance) 25 mg in people with Diabete Mellitus and Heart Failure, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study is investigating how the medication Empagliflozin affects the heart's structure and function in patients with heart disease. Empagliflozin is already used to treat diabetes and heart conditions, and this research aims to see if it can help improve heart remodeling, which may lead to better heart health and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Mellitus, Heart Failure, Remodeling, Left Ventricle
- What is being tested?
- Empagliflozin 10 MG [Jardiance] and empagliflozin (Jardiance) 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2023to 17 Jun 2025
- Phase
- Phase 2
- 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
Who may be able to join
- Diabetic patients with anterior STEMI with reduced LVEF who underwent PPCI with successful revascularization and resulting into TIMI III flow and who are receiving SGLTi for the first time.
Who cannot join
- patients who did not undergo primary PCI, those treated medically or had thrombolysis
- Non diabetic patient.
- Diabetic patient already on SGLTi
- STEMIs other than anterior.
- NSTEMI patients.
- Patients having valvular heart diseases.
- Patients having renal impairment.
- Patients with LV myopathies of non-ischemic origin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Empagliflozin 10 vs 25 mg on LV Remodeling in Diabetic Patients With Anterior STEMI With Reduced LVEF Who Underwent Primary PCI
This study is investigating how the medication Empagliflozin affects the heart's structure and function in patients with heart disease. Empagliflozin is already used to treat diabetes and heart conditions, and this research aims to see if it can help improve heart remodeling, which may lead to better heart health and quality of life. Participants will receive the medication and have regular check-ups to monitor their progress. The study is carefully designed to ensure participant safety. If you have heart disease and want to learn more, please contact (hany_barsoum@med.asu.edu.eg).
Read the detailed description
Heart disease is a leading cause of illness worldwide, and new treatments that improve heart function can have a significant impact on patient health and longevity. This research could provide valuable insights into how existing medications can be used to benefit people with heart conditions beyond their current use.
This clinical study aims to understand how Empagliflozin, a medication commonly used to treat diabetes, affects the heart's structure and function in people with heart disease. When the heart is damaged, especially on the left side (left ventricle), it can change shape and size-a process called remodeling-which may reduce how well the heart pumps blood. This study will explore whether Empagliflozin can help reverse or improve this remodeling process, potentially leading to better heart function and improved quality of life.
Participants in the study will receive Empagliflozin and undergo regular health check-ups, including imaging tests like echocardiograms, to track changes in heart structure and performance. The study is designed to carefully monitor safety and effectiveness, ensuring participants are supported throughout.
If you or a loved one has heart disease and are interested in learning more about this study, please contact [hany_barsoum@med.asu.edu.eg].
- Conditions
- Diabete Mellitus, Heart Failure, Remodeling, Left Ventricle
- Being tested
- Empagliflozin 10 MG [Jardiance], empagliflozin (Jardiance) 25 mg
- Keywords
- Empagliflozin, Heart Failure, Left Ventricular Remodeling, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Heart Failure, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MG [Jardiance]Drug
This intervention consists of Empagliflozin 10 mg oral tablets administered once daily for a duration of 6 months. The drug is used in this study to evaluate its effect on left ventricular remodeling in patients with heart failure. Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor approved for the treatment of type 2 diabetes and heart failure. In this trial, it is being investigated specifically for its impact on cardiac structure and function.
empagliflozin (Jardiance) 25 mgDrug
This intervention consists of Empagliflozin 25 mg oral tablets administered once daily for a duration of 6 months. The drug is used in this study to evaluate its effect on left ventricular remodeling in patients with heart failure. Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor approved for the treatment of type 2 diabetes and heart failure. In this trial, it is being investigated specifically for its impact on cardiac structure and function.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin 10 mg | Experimental | Participants in this arm will receive Empagliflozin 10 mg orally once daily for a duration of 6 months. The purpose is to evaluate the effect of Empagliflozin on left ventricular remodeling and cardiac function in patients with HFrEF. Standard heart failure therapy may be continued alongside the study drug as clinically indicated. Receives: Drug: Empagliflozin 10 MG [Jardiance] |
| Empagliflozin 25 mg | Experimental | Participants in this arm will receive Empagliflozin 25 mg orally once daily for a duration of 6 months. The purpose is to evaluate the effect of Empagliflozin on left ventricular remodeling and cardiac function in patients with HFrEF. Standard heart failure therapy may be continued alongside the study drug as clinically indicated. Receives: Drug: empagliflozin (Jardiance) 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular remodeling
change of left ventricular volumes form baseline and after 6 months
Measured: 6 months
left ventricular systolic function
change of left ventricular ejection fraction from baseline and after 6 months
Measured: 6 months
left ventricular Global Longitudinal Strain (GLS)
changes of GLS from baseline and after 6 months
Measured: 6 months
Secondary outcomes (3)
Incidence of Major Adverse Cardiovascular Events (MACE)
MACE is defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.
Measured: 6 months
Assessment of diastolic function
studying the effect of different doses of Empagliflozin not only on systolic function but also on diastolic function with E/E'
Measured: 6 months
Left Atrial Strain
studying the effect of different doses of Empagliflozin on Left Atrial Strain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start12 Jul 2023
- Primary completion23 Feb 2025
- Study completion17 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zainab A. Fahmy, Professor of Cardiology, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169981
- Sponsor's protocol ID
- FMASU MD 100/2023
- Acronym
- EMPA-DMMI
- Status last verified
- Jul 2025
- First submitted
- 20 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Empagliflozin 10 vs 25 mg on LV Remodeling in Diabetic Patients With Anterior STEMI With Reduced LVEF Who Underwent Primary PCI
- ClinicalTrials.gov ID
- NCT07169981
- Acronym / sponsor ID
- EMPA-DMMI / FMASU MD 100/2023
- Conditions
- Diabete Mellitus, Heart Failure, Remodeling, Left Ventricle
- Keywords
- Empagliflozin, Heart Failure, Left Ventricular Remodeling, Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 23 Feb 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 12 Sep 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 is investigating how the medication Empagliflozin affects the heart's structure and function in patients with heart disease. Empagliflozin is already used to treat diabetes and heart conditions, and this research aims to see if it can help improve heart remodeling, which may lead to better heart health and quality of life. Participants will receive the medication and have regular check-ups to monitor their progress. The study is carefully designed to ensure participant safety. If you have heart disease and want to learn more, please contact (hany_barsoum@med.asu.edu.eg).
Detailed description
Heart disease is a leading cause of illness worldwide, and new treatments that improve heart function can have a significant impact on patient health and longevity. This research could provide valuable insights into how existing medications can be used to benefit people with heart conditions beyond their current use.
This clinical study aims to understand how Empagliflozin, a medication commonly used to treat diabetes, affects the heart's structure and function in people with heart disease. When the heart is damaged, especially on the left side (left ventricle), it can change shape and size-a process called remodeling-which may reduce how well the heart pumps blood. This study will explore whether Empagliflozin can help reverse or improve this remodeling process, potentially leading to better heart function and improved quality of life.
Participants in the study will receive Empagliflozin and undergo regular health check-ups, including imaging tests like echocardiograms, to track changes in heart structure and performance. The study is designed to carefully monitor safety and effectiveness, ensuring participants are supported throughout.
If you or a loved one has heart disease and are interested in learning more about this study, please contact [hany_barsoum@med.asu.edu.eg].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin 10 mg | Experimental | Drug: Empagliflozin 10 MG [Jardiance]Participants in this arm will receive Empagliflozin 10 mg orally once daily for a duration of 6 months. The purpose is to evaluate the effect of Empagliflozin on left ventricular remodeling and cardiac function in patients with HFrEF. Standard heart failure therapy may be continued alongside the study drug as clinically indicated. |
| Empagliflozin 25 mg | Experimental | Drug: empagliflozin (Jardiance) 25 mgParticipants in this arm will receive Empagliflozin 25 mg orally once daily for a duration of 6 months. The purpose is to evaluate the effect of Empagliflozin on left ventricular remodeling and cardiac function in patients with HFrEF. Standard heart failure therapy may be continued alongside the study drug as clinically indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patients with anterior STEMI with reduced LVEF who underwent PPCI with successful revascularization and resulting into TIMI III flow and who are receiving SGLTi for the first time.
Key exclusion criteria (8 listed)
- patients who did not undergo primary PCI, those treated medically or had thrombolysis
- Non diabetic patient.
- Diabetic patient already on SGLTi
- STEMIs other than anterior.
- NSTEMI patients.
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 |
|---|---|---|
| Empagliflozin 10 MG [Jardiance]This intervention consists of Empagliflozin 10 mg oral tablets administered once daily for a duration of 6 months. The drug is used in this study to evaluate its effect on left ventricular remodeling in patients with heart failure. Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor approved for the treatment of type 2 diabetes and heart failure. In this trial, it is being investigated specifically for its impact on cardiac structure and function. | Drug | Empagliflozin 10 mg |
| empagliflozin (Jardiance) 25 mgThis intervention consists of Empagliflozin 25 mg oral tablets administered once daily for a duration of 6 months. The drug is used in this study to evaluate its effect on left ventricular remodeling in patients with heart failure. Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor approved for the treatment of type 2 diabetes and heart failure. In this trial, it is being investigated specifically for its impact on cardiac structure and function. | Drug | Empagliflozin 25 mg |
Primary outcome
left ventricular remodeling
Time frame: 6 months
change of left ventricular volumes form baseline and after 6 months
left ventricular systolic function
Time frame: 6 months
change of left ventricular ejection fraction from baseline and after 6 months
left ventricular Global Longitudinal Strain (GLS)
Time frame: 6 months
changes of GLS from baseline and after 6 months
3 secondary outcomes
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: 6 months
Assessment of diastolic function
Time frame: 6 months
Left Atrial Strain
Time frame: 6 months
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 12 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Zainab A. Fahmy, Professor of Cardiology study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin 10 MG [Jardiance] and empagliflozin (Jardiance) 25 mg in people with Diabete Mellitus and Heart Failure, run by Ain Shams 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 1 inclusion and 8 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 12 Sep 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
left ventricular remodeling (time frame: 6 months). The study lists 3 primary outcomes in all. 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 12 Sep 2025.