Endothelial Dysfunction in Post-infection Fatigue Syndromes

NCT06463106 | Completed

• 1 other identifier: FWF_KLP9628023
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Post-infection chronic fatigue syndromes, such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-COVID-19 condition (Long Covid), are conditions primarily characterized by debilitating fatigue. This fatigue can range from mild, where patients are still able to participate in some social activities (e.g., school, work), to moderate and severe, where sufferers are predominantly homebound and bedridden. As a result, ME/CFS and Long Covid not only negatively impact the quality of life of affected individuals and their caregivers but also represent a substantial and often silent burden on healthcare systems worldwide, including Austria. This is primarily because most cases remain undiagnosed due to the lack of standardized clinical assessments and diagnostic markers. Endothelial dysfunction, which is well known to affect blood flow, oxygen and nutrient delivery, and waste removal in the body, has been described as one of the key factors behind the symptoms experienced by ME/CFS and Long Covid patients. However, the mechanisms that might explain the development of endothelial dysfunction remain largely unexplored. Therefore, this project aims to evaluate key biological aspects related to the function of endothelial cells - a layer of cells lining blood vessels - using plasma samples from an Austrian cohort of ME/CFS and Long Covid patients. We expect that the findings from our study will provide new insights to better understand endothelial dysfunction in post-infection chronic fatigue syndromes, leading to improved patient stratification and tailored treatment alternatives.

Conditions

Chronic Fatigue Syndrome; Long COVID

Keywords

ME/CFS; Long COVID; Endothelial dysfunction

Outcome Measures

Primary Outcomes (6)

• Circulating levels of L-arginine metabolites

  Ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS)

  6 months

• Markers of endothelial inflammation

  ELISA

  6 months

• Production of reactive oxygen species (ROS) in endothelial cells

  Fluorometric assay

  6 months

• Endothelial permeability

  3D culture model

  6 months

• Angiogenesis

  3D culture model

  6 months

• Epigenetic and transcriptomic patterns in endothelial cells

  Genome wide DNA methylation and RNA sequencing (RNA-seq)

  6 months

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A sex/age-matched cohort (n=107) including (1) healthy controls and patients diagnosed with (2) ME/CFS and (3) Long-Covid according to the ethical approval granted by the Ethics Committee at the Medical University of Vienna (vote number: 2281/2020). Healthy individuals will be divided into two sub-groups: individuals without SARS-CoV-2 infection (HC1; n=30; females: 73.4%; age (years): 34.37 ± 12.30) and previously SARS-CoV-2 infected, fully convalescent patients (HC2; n=30; females: 73.4%; age (years): 34.10 ± 11.51).

Sponsors & Collaborators

• FH Joanneum Gesellschaft mbH: lead

Study Sites (1)

FH JOANNEUM University of Applied Sciences

Graz, 8020, Austria

Location

Related Publications (3)

• Pipper C, Bliem L, Leon LE, Mennickent D, Bodner C, Guzman-Gutierrez E, Stingl M, Untersmayr E, Wagner B, Bertinat R, Sepulveda N, Westermeier F. Sex and disease severity-based analysis of steroid hormones in ME/CFS. J Endocrinol Invest. 2024 Sep;47(9):2235-2248. doi: 10.1007/s40618-024-02334-1. Epub 2024 May 10.

  PMID: 38724880 BACKGROUND

• Bertinat R, Villalobos-Labra R, Hofmann L, Blauensteiner J, Sepulveda N, Westermeier F. Decreased NO production in endothelial cells exposed to plasma from ME/CFS patients. Vascul Pharmacol. 2022 Apr;143:106953. doi: 10.1016/j.vph.2022.106953. Epub 2022 Jan 21.

  PMID: 35074481 BACKGROUND

• Blauensteiner J, Bertinat R, Leon LE, Riederer M, Sepulveda N, Westermeier F. Altered endothelial dysfunction-related miRs in plasma from ME/CFS patients. Sci Rep. 2021 May 19;11(1):10604. doi: 10.1038/s41598-021-89834-9.

  PMID: 34011981 BACKGROUND

Related Links

• FWF / Austrian Science Fund

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: June 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: December 1, 2022
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

AU (1)