Clinical trial NCT06585761: Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients
Official title: Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: participants who are candidates for SGLT2i and will be recruited from Cardiology Department, Kafrelshiekh University Hospital.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: measure effect of SGLT2I ON serum concentration ( level) of cardiac biomarkers in heart failure patients before and after the intervention
timeFrame: 1 year
measure: clinical examination for the presence and extent of improvement in signs and symptoms
timeFrame: 1 year
Secondary outcomes:
measure: measure effect of SGLT2I ON serum concentration ( level) of cardiac inflammatory marker ( IL-6) in heart failure patients before and after the intervention
timeFrame: 1 year
measure: Measure the effect of SGLT2I on serum concentration ( level) of cardiac inflammatory marker ( TNF-Alpha) in heart failure patients before and after the intervention
timeFrame: 1 year
Other outcomes:
measure: measure effect of SGLT2I ON serum concentration( level) of cardiac stress markers in heart failure patients before and after the intervention
timeFrame: 1 year
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University Hospital
Study officials:
affiliation: clinical pharmacy department, kafrelsheikh university
name: Nada Nabil Mohammed Elsalhey, Bsc
role: PRINCIPAL_INVESTIGATOR
References: