Effect of Genetic Polymorphisms on the Clinical Response to SGLT2 Inhibitors in Heart Failure Patients

O

October 6 University

Status

Enrolling

Conditions

Heart Failure
Genetic Polymorphisms

Treatments

Drug: SGLT2 inhibitors (Dapagliflozin and Empagliflozin)

Study type

Observational

Funder types

Other

Identifiers

NCT06201000
IHC00068

Details and patient eligibility

About

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.

Full description

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.

Enrollment

282 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

282 participants in 1 patient group

Heart Failure Patients with reduced or preserved Ejection Fraction
Description:
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.
Treatment:
Drug: SGLT2 inhibitors (Dapagliflozin and Empagliflozin)

Trial contacts and locations

1

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Central trial contact

Ahmed Essam, MSc

Data sourced from clinicaltrials.gov

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