Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06585761

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kafrelsheikh University Hospital

Kafr ash Shaykh, 33516, Egypt

Location status: Recruiting

Location contact

Nada Nabil Mohammed Elsalhey, Bsc

CONTACT

[email protected]

01062787805

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

SGLT2 inhibitor

Drug

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

Other names: empagliflozin, Dapagliflozin

echo cardiogram

Device

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

Primary outcomes

  1. measure effect of SGLT2I ON serum concentration ( level) of cardiac biomarkers in heart failure patients before and after the intervention

    Time frame: 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.

  2. clinical examination for the presence and extent of improvement in signs and symptoms

    Time frame: 1 year

    Clinical examination depending on NYHA classification of the participants

Secondary outcomes

  1. measure effect of SGLT2I ON serum concentration ( level) of cardiac inflammatory marker ( IL-6) in heart failure patients before and after the intervention

    Time frame: 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

  2. Measure the effect of SGLT2I on serum concentration ( level) of cardiac inflammatory marker ( TNF-Alpha) in heart failure patients before and after the intervention

    Time frame: 1 year

    TNF-Alpha serum concentration is measured in pg/ml

Other outcomes

  1. measure effect of SGLT2I ON serum concentration( level) of cardiac stress markers in heart failure patients before and after the intervention

    Time frame: 1 year

    At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarkers such as MDA which plasma concentration is measured in nM

Study contacts

Contact information is provided by the study sponsor or research team.

Nada Nabil mohammed elsalhey, BSC

CONTACT

[email protected]

+201062787805

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.