COVID-19, Endothelial Dysfunction
Conditions
Keywords
COVID-19, Arterial Stiffness, Endothelial Glycocalyx, Coronary microcirculation, Left ventricular myocardial deformation
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTFood supplement Endocalyx
Patients with COVID-19 infection will be randomized to receive food supplement Endocalyx for 4 months.
DIETARY_SUPPLEMENTPlacebo
Patients with COVID-19 infection will be randomized to receive placebo for 4 months.
Sponsors
University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Sixty patients with COVID-19 infection will be randomized to receive food supplement Endocalyx (n=30) or placebo (n=30) for 4 consecutive months.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* caucasian patients * hospitalization for COVID-19 infection * diagnosis of COVID-19 proven by PCR
Exclusion criteria
* 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 * Asthma * Chronic kidney disease (estimated glomerular filtration rate \[eGFR\] ≤60 ml/min/1.73 m2) * Liver failure * Malignancies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endocalyx effects on endothelial glycocalyx thickness | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endocalyx effects on arterial stiffness | four months | Endocalyx effects on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry. |
| Endocalyx effects on coronary microcirculation | four months | Endocalyx effects on coronary function as assessed by measuring coronary flow reserve of left anterior descending artery. Coronary flow reserve is estimated by Doppler echocardiography as the ratio of coronary flow velocity (m/s) after bolus intravenous adenosine infusion to coronary flow velocity (m/s) at rest. |
| Endocalyx effects on left ventricular myocardial function | four months | Endocalyx effects on left ventricular function as assessed by global longitudinal strain using speckle-tracking echocardiography. |
Countries
Greece
Contacts
Primary ContactIgnatios Ikonomidis, Professor
Backup ContactAikaterini Kountouri, MD
Outcome results
None listed