RecruitingNCT06585761

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


Sponsor

Kafrelsheikh University

Enrollment

60 participants

Start Date

Feb 15, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria10

  • Patients aged more than 18 years old.
  • Patients are with cardiac function was graded as II-IV by the New York Heart Association (NYHA)
  • 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.
  • All patients signed the informed consent.

Exclusion Criteria5

  • 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.
  • Patients with various cardiac conditions, such as severe congenital heart disease, myocarditis, and valvular heart disease.
  • Female patients during pregnancy or lactation
  • Individuals suffering from a malignant tumor, hyperfunctioning thyroid, multiple organ failure, or significantly reduced kidney function (eGFR \<20 mL/min/1.73 m²).
  • Individuals suffering from verbal communication disorders or psychic cognitive impairment.

Interventions

DEVICEecho cardiogram

the patients are subjected to ECHO to determine their EF prior to and post the study

DRUGSGLT2 inhibitor

patients with HF are subjected to regular dose of SGLT2I member according to patient status.


Locations(1)

Kafrelsheikh University Hospital

Kafr ash Shaykh, Egypt

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NCT06585761


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