Diagnostic and Prognostic Roles of Inflammatory Biomarkers in Coronary Heart Disease and Heart Failure Patients Treated With Empagliflozin.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- All Cause 90 day hosptial admission
研究概览
简要总结
The association of novel inflammatory biomarkers with cardiovascular diseases is still obscure. The present study aimed to investigate the relationship of various inflammatory biomarkers with the existence as well as the extent of heart failure (HF) and coronary artery disease (CAD), suggesting a link between inflammation and cardiovascular diseases and all-cause 30- and -90 day of hospital readmission. Methods: We enrolled a total of 120 patients with HF, asymptomatic CAD and 60 healthy controls (HC) without cardiovascular diseases.
详细描述
- The present study aimed to investigate the relationship of various inflammatory biomarkers with the existence as well as the extent of heart failure (HF) and coronary artery disease (CAD), suggesting a link between inflammation and cardiovascular diseases and all-cause 30- and -90 day of hospital readmission in patients on empagliflozin 10 mg once daily for 6 months before the beginning of the study.
- We enrolled a total of 60 patients with HF, 60 asymptomatic CAD patients and 60 healthy controls (HC) without cardiovascular diseases.
Group I: 60 Healthy Subjects. Group II: 60 Patients with Stable Angina (asymptomatic CAD). Group III: 60 Patients with Heart Failure.
- Clinical parameters, glycemic and lipid profile, vaspin, visfatin, high-sensitivity C-reactive protein, sortilin, homocysteine, troponin I, fetuin A and lipoprotein A levels were assayed.
- Patients will be followed up to assess all-cause 30- and -90 day of hospital readmission.
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
- •Either sex, aged 18 years or older.
- •new-onset AHF or acute decompensation of chronic HF,
- •CAD (including previous myocardial infarction, previous percutaneous or surgical coronary revascularization, or angiographic evidence that one or more major coronary arteries had narrowed by 50% or more).
- •On empagliflozin 10 mg once daily for 6 months before the beginning of the study.
排除标准
- •severe liver/
- •kidney dysfunction;
- •severe systemic disease (such as the diseases of respiratory system/ digestive system/ nervous system etc.);
- •malignant tumor;
- •acute/ chronic infectious diseases;
- •autoimmune disease or connective tissue disease;
- •major trauma or surgical operation over the past three months.
研究组 & 干预措施
Group I
60 Healthy Subjects.
干预措施: Group I Healthy (Other)
Group II
60 Patients with Stable Angina on empagliflozin 10 mg once daily for 6 months before the beginning of the study.
干预措施: CAD-Empagliflozin 10 mg once daily for 6 months before the beginning of the study (Drug)
Group III
60 Patients with Heart Failure on empagliflozin 10 mg once daily for 6 months before the beginning of the study.
干预措施: HF-Empagliflozin 10 mg once daily for 6 months before the beginning of the study (Drug)
结局指标
主要结局
All Cause 90 day hosptial admission
时间窗: 3 months
Number of patients admited to hospital during 3 month.
All Cause 30 day hosptial admission
时间窗: 1 month
Number of patients admited to hospital during 1 month.
vaspin (ng/ml)
时间窗: 1 month
vaspin blood concentration
Homocystien(umol/L)
时间窗: 1 Month
Homocystien blood concentration
visfatin (ng/ml)
时间窗: 1 month
visfatin blood concentration
Troponin.I (ng/ml)
时间窗: 1 Month
Troponin.I blood concentration
Sortillin (pg/ml)
时间窗: 1 month
Sortillin blood concentration
次要结局
未报告次要终点
研究者
Rehab Werida
Associate Professor
Damanhour University