Effect of Genetic Polymorphism on the Clinical Outcome to SGLT2 Inhibitors in Heart Failure Patients

NCT06901609 | Active Not Recruiting DMC

• 1 other identifier: SGLT2 INHIBITORS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure with reduced ejection fraction (HFrEF) is a significant cause of morbidity and mortality. Sodium-glucose co-transporter-2 (SGLT2) inhibitors have demonstrated efficacy in improving renal outcomes in patients with HFrEF. Pharmacogenetics, the study of how genetic variations influence drug response, could elucidate inter-individual variability in treatment outcomes. This study aims to assess the impact of specific genetic variants on renal outcomes in HFrEF patients treated with SGLT2 inhibitors.

Conditions

Heart Failure - NYHA II - IV; Cardiac Fibrosis; Cardiac Remodeling

Keywords

SGLT2 inhibitors; Heart Failure with reduced ejection fraction; Cardiac Remodeling

Outcome Measures

Primary Outcomes (1)

• Reno-protective effect and gene polymorphism

  Association between genetic polymorphism in SLC5A2, UMOD and ACE and Renal response in-terms of change in GFR among patients with heart failure.

  6 months

Secondary Outcomes (1)

• Gene polymorphisms and Renal biomarkers

  6 months

Study Arms (1)

Cohort A

Newly diagnosed Heart Failure patients with reduced ejection fraction who are candidate for add-on treatment with sodium glucose transporter 2 inhibitor (SGLT2i) for the first time in addition to standard heart failure therapy.

Drug: SGLT2 inhibitor (Dapagliflozin 10mg)

Interventions

SGLT2 inhibitor (Dapagliflozin 10mg) DRUG

Renal response after 6 months of Dapagliflozin therapy among patients with heart failure reduced ejection fraction.

Cohort A

Eligibility Criteria

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

Study Population

Heart Failure patients with reduced ejection fraction (LVEF\<40%)

You may qualify if:

• Adults (≥18 years) with HFrEF (LVEF ≤40%).
• Initiation of SGLT2 inhibitor therapy.
• Stable background HF therapy for at least 4 weeks.
• Written informed consent for participation and genetic testing.

You may not qualify if:

• Known hypersensitivity to SGLT2 inhibitors.
• History of ketoacidosis or recurrent urinary tract infections.
• End-stage renal disease (eGFR \<30 mL/min/1.73 m²).
• Life expectancy \<6 months due to non-cardiovascular conditions.
• Pregnancy or lactation.

Sponsors & Collaborators

• Ain Shams University: lead
• National Heart Institute in Egypt: collaborator
• Misr International University: collaborator
• Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia: collaborator

Study Sites (1)

National Heart Institute

Cairo, 11315, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples will be collected and stored in - 20°C environment for DNA extraction by DNA extraction kit according to manufacturer recommendation.

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitors; dapagliflozin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Bassem Zarif, MD

  National Heart Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: November 22, 2023
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

EG (1)