Diabete Mellitus, Heart Failure, Remodeling, Left Ventricle
Conditions
Keywords
Empagliflozin, Heart Failure, Left Ventricular Remodeling, Diabetes Mellitus
Brief 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 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 \[hany\_barsoum@med.asu.edu.eg\].
Interventions
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.
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
1. patients who did not undergo primary PCI, those treated medically or had thrombolysis 2. Non diabetic patient. 3. Diabetic patient already on SGLTi 4. STEMIs other than anterior. 5. NSTEMI patients. 6. Patients having valvular heart diseases. 7. Patients having renal impairment. 8. Patients with LV myopathies of non-ischemic origin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| left ventricular remodeling | 6 months | change of left ventricular volumes form baseline and after 6 months |
| left ventricular systolic function | 6 months | change of left ventricular ejection fraction from baseline and after 6 months |
| left ventricular Global Longitudinal Strain (GLS) | 6 months | changes of GLS from baseline and after 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left Atrial Strain | 6 months | studying the effect of different doses of Empagliflozin on Left Atrial Strain |
| Incidence of Major Adverse Cardiovascular Events (MACE) | 6 months | MACE is defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. |
| Assessment of diastolic function | 6 months | studying the effect of different doses of Empagliflozin not only on systolic function but also on diastolic function with E/E' |
Countries
Egypt
Outcome results
None listed