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| Name | Class |
|---|---|
| University of Florida | OTHER |
| National Heart Institute, Egypt | OTHER_GOV |
| Beni-Suef University | OTHER |
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Sodium-glucose cotransporter 2 (SGLT2) inhibitors have shown further reductions in heart failure hospitalization, cardiovascular events, and mortality, especially for heart failure patients.
The SGLT2 gene, also known as SLC5A2 (solute carrier family 5 member 2), is located on chromosome 16 and is responsible for encoding SGLT2.
Several SLC5A2 mutations alter SGLT2 expression, membrane location, or transporter function.
Several common genetic variations were found in the SLC5A2 gene that may affect the response to treatment with SGLT2 inhibitors.
Sodium-glucose cotransporter-2 inhibitors (SGLT-2i), which were first investigated and licensed for the treatment of diabetes, are now emerging as a promising class of drugs for the treatment of heart failure (HF), even in people without diabetes.
Significant reductions in worsening heart failure or cardiovascular death were shown under treatment with dapagliflozin and empagliflozin in the trials of patients with heart failure.
Several common genetic variations were found in the SLC5A2 gene that may affect the response to treatment with SGLT2 inhibitors.
The most recent SLC5A2 Single Nucleotide Polymorphisms (SNPs) that reduce the risk of heart failure included two intronic SLC5A2 SNPs, s9934336, and rs3116150, both associated with the expression levels of the transporter.
This study aims to detect the association between SLC5A2 single nucleotide polymorphisms and variability in response to SGLT2 Inhibitors as well as the association between cardiac biomarkers and non-coding RNA in patients with Heart Failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Failure Patients with reduced or preserved Ejection Fraction | Patients with reduced or preserved ejection fraction that have received the Guided Therapy (β-blockers, Diuretics, Angiotensin-converting enzyme (ACE) inhibitors or Angiotensin receptor blockers (ARBs) or Angiotensin Receptor-Neprilysin Inhibitor (ARNi) and Mineralocorticoid receptor antagonists (MRAs) then Sodium-glucose cotransporter-2 inhibitors (SGLT-2i) (10 mg of dapagliflozin or empagliflozin) will be added at the study entry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGLT2 inhibitors (Dapagliflozin and Empagliflozin) | Drug | 10 mg of dapagliflozin or empagliflozin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median / Mean of Left Ventricular Ejection Fraction (LVEF) among studied genetic polymorphisms | Change in median / mean of Left Ventricular Ejection Fraction (LVEF) before and after drug administration | 6 months |
| Median / Mean of Left Ventricular End Systolic Volumes among studied genetic polymorphisms | Change in median / mean of Left Ventricular End Systolic Volume (LVESV) | 6 months |
| Median / Mean of Left Ventricular End Diastolic Volumes among studied genetic polymorphisms | Change in median / mean of Left Ventricular End Diastolic Volume (LVEDV) before and after drug administration | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median / Mean of quality of life measure {Kansas City Cardiomyopathy Questionnaire (KCCQ-12)} among studied genetic polymorphisms | Change in median / mean of Kansas City Cardiomyopathy Questionnaire (KCCQ-12) before and after drug administration | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consist of established Heart failure with reduced ejection fraction (HFrEF) or Heart failure with preserved ejection fraction (HFpEF) and New York Heart Association (NYHA) functional classes II-III, who will be candidates for add-on treatment with SGLT2i.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Essam, MSc | Contact | +201007647696 | ahmed.essam@o6u.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Rania Sarhan, PhD | Beni-Suef University | Study Director |
| Neven Sarhan, PhD | Misr International University | Study Director |
| Bassem Zarif, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32610 | United States |
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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 |
| C529054 | dapagliflozin |
| C570240 | empagliflozin |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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|
| National Heart Institute |
| Study Director |
| Julio Duarte, PhD | University of Florida | Study Chair |
| D045505 | Physiological Effects of Drugs |