Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- measure effect of SGLT2I ON serum concentration ( level) of cardiac biomarkers in heart failure patients before and after the intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
pre-SGLT2I group
patients with heart failure newly introduced to one of SGLT2I members
干预措施: echo cardiogram (Device)
Post-SGLT2I group
patients with heart failure on one of SGLT2I members for at least 2 months
干预措施: SGLT2 inhibitor (Drug)
Post-SGLT2I group
patients with heart failure on one of SGLT2I members for at least 2 months
干预措施: echo cardiogram (Device)
结局指标
主要结局
measure effect of SGLT2I ON serum concentration ( level) of cardiac biomarkers in heart failure patients before and after the intervention
时间窗: 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
时间窗: 1 year
Clinical examination depending on NYHA classification of the participants
次要结局
- 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)
- 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)
研究者
Nada Nabil Elsalhey
Dr
Kafrelsheikh University