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The aim of this study is to explore the effect of SGLT2i on the levels of cardiac biomarkers, inflammatory and stress markers in Egyptian heart failure patients to provide a better understanding of mechanism that might assist in tailoring treatment strategies in patients with various forms of HF especially in Egyptian population. Also understand how biomarkers may be employed to predict risk in patients receiving SGLT2i or identification of those who may derive the most benefit from SGLT2i in the means of individualized medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pre-SGLT2I group | patients with heart failure newly introduced to one of SGLT2I members |
| |
| Post-SGLT2I group | patients with heart failure on one of SGLT2I members for at least 2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGLT2 inhibitor | Drug | patients with HF are subjected to regular dose of SGLT2I member according to patient status. |
|
| Measure | Description | Time Frame |
|---|---|---|
| measure effect of SGLT2I ON serum concentration ( level) of cardiac biomarkers in heart failure patients before and after the intervention | At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarkers the studied biomarker is NT-proBNP, its concentration is measured in pg/mL. | 1 year |
| clinical examination for the presence and extent of improvement in signs and symptoms | Clinical examination depending on NYHA classification of the participants | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| measure effect of SGLT2I ON serum concentration ( level) of cardiac inflammatory marker ( IL-6) in heart failure patients before and after the intervention | At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarker Il-6 serum concentration is measured in pg/mL | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| measure effect of SGLT2I ON serum concentration( level) of cardiac stress markers in heart failure patients before and after the intervention | At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarkers such as MDA which plasma concentration is measured in nM | 1 year |
Inclusion Criteria:
Patients aged more than 18 years old.
Patients are with cardiac function was graded as II-IV by the New York Heart Association (NYHA)
Patients are on standard therapy for management of HF (according to AHA/ACC/HFSA Guideline for the Management of Heart Failure2022)21 such as:
All patients signed the informed consent.
Exclusion Criteria:
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participants who are candidates for SGLT2i and will be recruited from Cardiology Department, Kafrelshiekh University Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nada Nabil mohammed elsalhey, BSC | Contact | +201062787805 | nada.nabil@pharm.kfs.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Nada Nabil Mohammed Elsalhey, Bsc | clinical pharmacy department, kafrelsheikh university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kafrelsheikh University Hospital | Recruiting | Kafr ash Shaykh | 33516 | Egypt |
not yet decided by participant
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| C570240 | empagliflozin |
| C529054 | dapagliflozin |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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serum sample
| echo cardiogram | Device | the patients are subjected to ECHO to determine their EF prior to and post the study |
|
| Measure the effect of SGLT2I on serum concentration ( level) of cardiac inflammatory marker ( TNF-Alpha) in heart failure patients before and after the intervention |
TNF-Alpha serum concentration is measured in pg/ml |
| 1 year |
| D045505 | Physiological Effects of Drugs |