The Effect of Dietary Glycocalyx Precursor Supplementation on Endothelial Function, on Markers of Vascular Function and on Cardiac Performance in Patients With COVID-19 Infection.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Endocalyx effects on endothelial glycocalyx thickness
研究概览
简要总结
The food supplement Endocalyx is considered to support the endothelial glycocalyx integrity by supplying sulfated polysaccharides, anti-oxidant enzymes and additional substrates for glycocalyx synthesis. The investigators will study the effect of Endocalyx on endothelial, vascular and left ventricular myocardial function in patients with COVID-19 infection.
详细描述
Sixty patients who have been hospitalized due to COVID-19 infection will be randomized to receive food supplement Endocalyx (4 capsules per day) (n=30) or placebo (n=30) for 4 consecutive months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •caucasian patients
- •hospitalization for COVID-19 infection
- •diagnosis of COVID-19 proven by PCR
排除标准
- •Pregnancy and breastfeeding
- •Foreseen inability to attend scheduled visits
- •History of acute coronary syndrome. Coronary artery disease will be excluded by a clinical history, examination and electrocardiogram.
- •Moderate or severe valve disease
- •Primary cardiomyopathies
- •Chronic obstructive pulmonary disease
- •Chronic kidney disease (estimated glomerular filtration rate [eGFR] ≤60 ml/min/1.73 m2)
- •Liver failure
- •Malignancies
结局指标
主要结局
Endocalyx effects on endothelial glycocalyx thickness
时间窗: four months
Endocalyx effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels using Sidestream Dark Field (SDF) imaging
次要结局
- Endocalyx effects on arterial stiffness(four months)
- Endocalyx effects on coronary microcirculation(four months)
- Endocalyx effects on left ventricular myocardial function(four months)
研究者
Ignatios Ikonomidis
Professor of Cardiology
University of Athens