Heart Failure
Conditions
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.
Interventions
DRUGSGLT2 inhibitor
patients with HF are subjected to regular dose of SGLT2I member according to patient status.
DEVICEecho cardiogram
the patients are subjected to ECHO to determine their EF prior to and post the study
Sponsors
Kafrelsheikh University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| measure effect of SGLT2I ON serum concentration( level) of cardiac stress markers 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 such as MDA which plasma concentration is measured in nM |
Countries
Egypt
Contacts
Primary ContactNada Nabil mohammed elsalhey, BSC
Outcome results
None listed