Exploring the effects of SGLT2 inhibitors on heart failure patients
Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients
This study is testing how a type of diabetes medication called SGLT2 inhibitors affects heart health and inflammation in people with heart failure in Egypt.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Kafrelsheikh University Academic / other |
| Locations | 1 site (Kafr ash Shaykh) |
| Trial ID | NCT06585761 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how Sodium Glucose Co-Transporter 2 Inhibitors (SGLT2i) affect levels of cardiac biomarkers, inflammatory markers, and oxidative stress in heart failure patients in Egypt. By analyzing these effects, the study seeks to enhance understanding of treatment strategies tailored to different forms of heart failure, particularly within the Egyptian population. The research will also explore the potential of biomarkers to predict patient risk and identify those who may benefit most from SGLT2i therapy.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with heart failure classified as NYHA functional class II-IV who are on standard heart failure therapy.
Not a fit: Patients with acute cardiovascular illnesses, severe sepsis, or other significant cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for heart failure patients, improving their outcomes.
How similar studies have performed: While the approach of using SGLT2 inhibitors in heart failure is gaining traction, this specific focus on inflammatory and oxidative stress markers in the Egyptian population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kafr ash Shaykh
- Kafrelsheikh University Hospital — Kafr ash Shaykh, Egypt (Recruiting)
Study contacts
- Principal investigator: Nada Nabil Mohammed Elsalhey, Bsc — clinical pharmacy department, kafrelsheikh university
- Study coordinator: Nada Nabil mohammed elsalhey, BSC
- Email: nada.nabil@pharm.kfs.edu.eg
- Phone: +201062787805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.