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Clinical Trials/NCT05185934
NCT05185934
Recruiting
Not Applicable

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.

University of Athens1 site in 1 country60 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
University of Athens
Enrollment
60
Locations
1
Primary Endpoint
Endocalyx effects on endothelial glycocalyx thickness
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
January 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Athens
Responsible Party
Principal Investigator
Principal Investigator

Ignatios Ikonomidis

Professor of Cardiology

University of Athens

Eligibility Criteria

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
  • Chronic kidney disease (estimated glomerular filtration rate \[eGFR\] ≤60 ml/min/1.73 m2)
  • Liver failure
  • Malignancies

Outcomes

Primary Outcomes

Endocalyx effects on endothelial glycocalyx thickness

Time Frame: 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 Outcomes

  • Endocalyx effects on arterial stiffness(four months)
  • Endocalyx effects on coronary microcirculation(four months)
  • Endocalyx effects on left ventricular myocardial function(four months)

Study Sites (1)

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