Effect of Genetic Polymorphisms on the Clinical Response to SGLT2 Inhibitors in Heart Failure Patients
Part of paid clinical trials in Gainesville, Florida.
- Sponsor
- October 6 University
- Study ID
- NCT06201000
- Status
- Unknown
Conditions
- Genetic Polymorphisms
- Heart Failure
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- SGLT2 inhibitors (Dapagliflozin and Empagliflozin) — DRUG10 mg of dapagliflozin or empagliflozin
Study Details
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.
Key Dates
- Start date
- Dec 27, 2023
- Status verified
- Feb 2024
- Primary completion
- Jul 1, 2024
- Completion
- Sep 1, 2024
Study Design
- Enrollment
- 282 participants (estimated)
Arms
- Arm: Heart Failure Patients with reduced or preserved Ejection FractionPatients 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.
Primary Outcome Measure
Median / Mean of Left Ventricular Ejection Fraction (LVEF) among studied genetic polymorphisms [ Time Frame: 6 months ]
Central Contacts
- Ahmed Essam, MSc+201007647696
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | Julio Duarte, PhD |
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