Recruiting

SGLT2 Inhibitors

Sponsor:

October 6 University

Code:

NCT06201000

Conditions

Genetic Polymorphisms

Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SGLT2 inhibitors (Dapagliflozin and Empagliflozin)

Study Details

Brief summary:

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.

Conditions

Genetic Polymorphisms

Heart Failure

Study ID

NCT06201000

Start date

Dec 27, 2023

Status verified date

Feb, 2024

Completion date

Sep 1, 2024

Anticipated

Primary completion date

Jul 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

282 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

SGLT2 inhibitors (Dapagliflozin and Empagliflozin)

10 mg of dapagliflozin or empagliflozin

Primary outcome measure

  • Median / Mean of Left Ventricular Ejection Fraction (LVEF) among studied genetic polymorphisms [ Time Frame: 6 months ]
  • Median / Mean of Left Ventricular End Systolic Volumes among studied genetic polymorphisms [ Time Frame: 6 months ]
  • Median / Mean of Left Ventricular End Diastolic Volumes among studied genetic polymorphisms [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Ahmed Essam, MSc

+201007647696ahmed.essam@o6u.edu.eg

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

More Information

Sponsor

October 6 University

Last update posted

Feb 7, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by October 6 University on 2024-02-07.