NCT06585761 Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients
| NCT ID | NCT06585761 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kafrelsheikh University |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-15 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-02-15 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Nada Nabil Mohammed Elsalhey, Bsc
PRINCIPAL INVESTIGATOR
clinical pharmacy department, kafrelsheikh university
Frequently Asked Questions
Who can join the NCT06585761 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06585761 currently recruiting?
Yes, NCT06585761 is actively recruiting participants. Contact the research team at nada.nabil@pharm.kfs.edu.eg for enrollment information.
Where is the NCT06585761 trial being conducted?
This trial is being conducted at Kafr ash Shaykh, Egypt.
Who is sponsoring the NCT06585761 clinical trial?
NCT06585761 is sponsored by Kafrelsheikh University. The principal investigator is Nada Nabil Mohammed Elsalhey, Bsc at clinical pharmacy department, kafrelsheikh university. The trial plans to enroll 60 participants.
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