Impact of genetic variations on heart failure treatment with SGLT2 inhibitors
Effect of Genetic Polymorphisms on the Clinical Response to Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors in Prevention of Cardiac Remodeling and Fibrosis in Heart Failure Patients
October 6 University · NCT06201000
This study is trying to see how certain genetic differences affect how well heart failure patients respond to SGLT2 inhibitors like dapagliflozin and empagliflozin.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 282 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | October 6 University (other) |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06201000 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how genetic polymorphisms in the SLC5A2 gene affect the clinical response to SGLT2 inhibitors, specifically dapagliflozin and empagliflozin, in patients with heart failure. It aims to identify associations between these genetic variations and treatment outcomes, as well as explore the relationship between cardiac biomarkers and non-coding RNA in this patient population. The study includes heart failure patients with varying left ventricular ejection fractions who are candidates for SGLT2 inhibitor therapy.
Who should consider this trial
Good fit: Ideal candidates include heart failure patients classified as NYHA class II to III with either reduced or preserved left ventricular ejection fraction.
Not a fit: Patients with contraindications to SGLT2 inhibitors or significant coronary artery diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies for heart failure patients based on their genetic profiles.
How similar studies have performed: While the approach of linking genetic polymorphisms to treatment response is being explored, this specific focus on SGLT2 inhibitors and heart failure is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Heart failure patients NYHA class II to III. * Heart failure patients with reduced left ventricular ejection fraction (LVEF) \< 45% or with preserved left ventricular ejection fraction (LVEF) \> 45% * Patients who will be candidate for add-on treatment with SGLT2. * Patients who will be able to sign informed consent to participate in the study. Exclusion Criteria: * Contraindications to SGLT2. * Significant coronary artery diseases (CAD), coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or valve surgery within 3 months. * Pregnant or breastfeeding women. * Patients with estimated glomerular filtration rates less than 30 mL/min/1.73 m2, as determined using the CKD-EPI equation.
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (RECRUITING)
Study contacts
- Study coordinator: Ahmed Essam, MSc
- Email: ahmed.essam@o6u.edu.eg
- Phone: +201007647696
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Genetic Polymorphisms, Heart Failure