Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients

Recruiting

• Conditions: Heart Failure
• Interventions: Device: echo cardiogram; Drug: SGLT2 inhibitor

• Registration Number: NCT06585761
• Lead Sponsor: Kafrelsheikh University

Brief Summary

The aim of this study is to explore the effect of SGLT2i on the levels of cardiac biomarkers, inflammatory and stress markers in Egyptian heart failure patients to provide a better understanding of mechanism that might assist in tailoring treatment strategies in patients with various forms of HF especially in Egyptian population. Also understand how biomarkers may be employed to predict risk in patients receiving SGLT2i or identification of those who may derive the most benefit from SGLT2i in the means of individualized medicine.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-15
• Study First Submitted: 2024-08-23
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-03
• Last Update Submitted: 2024-09-03
• Study First Posted: 2024-09-05
• Last Update Posted: 2024-09-05
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients aged more than 18 years old.

2. Patients are with cardiac function was graded as II-IV by the New York Heart Association (NYHA)

3. Patients are on standard therapy for management of HF (according to AHA/ACC/HFSA Guideline for the Management of Heart Failure2022)21 such as:

   • ACEi (angiotensin converting enzyme inhibitor)
   • ARB (angiotensin receptor blocker)
   • ARNI in place of ACEi OR ARB
   • Beta blocker
   • (MRA) Mineralocorticoid receptor antagonists
   • Diuretics as needed.

4. All patients signed the informed consent.

Exclusion Criteria

1. Patients suffering from conditions like acute CVS illness and severe sepsis that raise inflammatory markers and may lead to cardiac dysfunction as opposed to heart failure.
2. Patients with various cardiac conditions, such as severe congenital heart disease, myocarditis, and valvular heart disease.
3. Female patients during pregnancy or lactation
4. Individuals suffering from a malignant tumor, hyperfunctioning thyroid, multiple organ failure, or significantly reduced kidney function (eGFR <20 mL/min/1.73 m²).
5. Individuals suffering from verbal communication disorders or psychic cognitive impairment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pre-SGLT2I group	echo cardiogram	patients with heart failure newly introduced to one of SGLT2I members
Post-SGLT2I group	SGLT2 inhibitor	patients with heart failure on one of SGLT2I members for at least 2 months
Post-SGLT2I group	echo cardiogram	patients with heart failure on one of SGLT2I members for at least 2 months

Primary Outcome Measures

Name	Time	Method
measure effect of SGLT2I ON serum concentration ( level) of cardiac biomarkers in heart failure patients before and after the intervention	1 year	At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarkers the studied biomarker is NT-proBNP, its concentration is measured in pg/mL.
clinical examination for the presence and extent of improvement in signs and symptoms	1 year	Clinical examination depending on NYHA classification of the participants

Secondary Outcome Measures

Name	Time	Method
measure effect of SGLT2I ON serum concentration ( level) of cardiac inflammatory marker ( IL-6) in heart failure patients before and after the intervention	1 year	At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarker; Il-6 serum concentration is measured in pg/mL
Measure the effect of SGLT2I on serum concentration ( level) of cardiac inflammatory marker ( TNF-Alpha) in heart failure patients before and after the intervention	1 year	TNF-Alpha serum concentration is measured in pg/ml

Trial Locations

Locations (1)

Kafrelsheikh University Hospital; 🇪🇬 Kafr Ash Shaykh, Egypt