Clinical trial

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

Name
IHC00068
Description
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.
Trial arms
Trial start
2023-12-27
Estimated PCD
2024-07-01
Trial end
2024-09-01
Status
Recruiting
Treatment
SGLT2 inhibitors (Dapagliflozin and Empagliflozin)
10 mg of dapagliflozin or empagliflozin
Arms:
Heart Failure Patients with reduced or preserved Ejection Fraction
Other names:
Forxiga, Jardiance
Size
282
Primary endpoint
Median / Mean of Left Ventricular Ejection Fraction (LVEF) among studied genetic polymorphisms
6 months
Median / Mean of Left Ventricular End Systolic Volumes among studied genetic polymorphisms
6 months
Median / Mean of Left Ventricular End Diastolic Volumes among studied genetic polymorphisms
6 months
Eligibility 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '6 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 282, 'type': 'ESTIMATED'}}
Updated at
2024-02-07

1 organization

1 product

2 indications