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

NCT06201000 | Recruiting DMC

• 1 other identifier: IHC00068
• Study Type: observational
• Target: 282
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Median / Mean of Left Ventricular Ejection Fraction (LVEF) among studied genetic polymorphisms

  Change in median / mean of Left Ventricular Ejection Fraction (LVEF) before and after drug administration

  6 months

• Median / Mean of Left Ventricular End Systolic Volumes among studied genetic polymorphisms

  Change in median / mean of Left Ventricular End Systolic Volume (LVESV)

  6 months

• Median / Mean of Left Ventricular End Diastolic Volumes among studied genetic polymorphisms

  Change in median / mean of Left Ventricular End Diastolic Volume (LVEDV) before and after drug administration

  6 months

Secondary Outcomes (1)

• Median / Mean of quality of life measure {Kansas City Cardiomyopathy Questionnaire (KCCQ-12)} among studied genetic polymorphisms

  6 months

Study Arms (1)

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.

Drug: SGLT2 inhibitors (Dapagliflozin and Empagliflozin)

Interventions

SGLT2 inhibitors (Dapagliflozin and Empagliflozin) DRUG

10 mg of dapagliflozin or empagliflozin

Also known as: Forxiga, Jardiance

Heart Failure Patients with reduced or preserved Ejection Fraction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consist of established Heart failure with reduced ejection fraction (HFrEF) or Heart failure with preserved ejection fraction (HFpEF) and New York Heart Association (NYHA) functional classes II-III, who will be candidates for add-on treatment with SGLT2i.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• October 6 University: lead
• University of Florida: collaborator
• National Heart Institute, Egypt: collaborator
• Beni-Suef University: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Sodium-Glucose Transporter 2 Inhibitors; dapagliflozin; empagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Rania Sarhan, PhD

  Beni-Suef University

  STUDY DIRECTOR

• Neven Sarhan, PhD

  Misr International University

  STUDY DIRECTOR

• Bassem Zarif, MD

  National Heart Institute

  STUDY DIRECTOR

• Julio Duarte, PhD

  University of Florida

  STUDY CHAIR

Central Study Contacts

Ahmed Essam, MSc

CONTACT

+201007647696; ahmed.essam@o6u.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer in Clinical Pharmacy Department

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 11, 2024
• Study Start: December 27, 2023
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

US (1)