Chronic Fatigue SyndromeNCT06463106
Endothelial Dysfunction in Post-infection Fatigue Syndromes
An observational study of Chronic Fatigue Syndrome and Long COVID, run by FH Joanneum Gesellschaft mbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome, Long COVID
- How many people
- 107 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2021to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- The inclusion criteria for ME/CFS patients not infected with SARS-CoV-2 (n=17; females: 70.59%; age (years): 40.10 ± 10.80) and Long-Covid patients (n=30; females: 73.4%; age (years): 37.70 ± 9.96) include profound fatigue and at least one of the following symptoms: PEM, autonomic dysfunction, and/or orthostatic intolerance. All participants were included only if they were at least 12 weeks past an acute EBV infection and/or 10 weeks past an acute SARS-CoV-2 infection, respectively. SARS-CoV-2 specific IgA (A) and IgG (B) antibody titers were measured using commercial test kits (Anti-SARS-CoV-2-ELISA (IgA) and Anti-SARS-CoV-2-QuantiVac-ELISA (IgG); Euroimmun, Germany) in plasma samples.
Who cannot join
- Participants' exclusion criteria included evidence of acute malignant diseases, diabetes mellitus, acute sepsis, chronic inflammatory gastrointestinal diseases, and frequent intake of analgesics, antacids, or antibiotics. Furthermore, no previously hospitalized SARS-CoV-2 patients were included, eliminating false-positive fatigue due to intensive care treatment, such as artificial respiration.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Fatigue Syndrome, Chronic, Post-Acute COVID-19 Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating levels of L-arginine metabolites
Ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS)
Measured: 6 months
Markers of endothelial inflammation
ELISA
Measured: 6 months
Production of reactive oxygen species (ROS) in endothelial cells
Fluorometric assay
Measured: 6 months
Endothelial permeability
3D culture model
Measured: 6 months
Angiogenesis
3D culture model
Measured: 6 months
Epigenetic and transcriptomic patterns in endothelial cells
Genome wide DNA methylation and RNA sequencing (RNA-seq)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jun 2021
- Primary completion30 Nov 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- FH Joanneum Gesellschaft mbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Francisco Westermeier, FH Joanneum Gesellschaft mbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463106
- Sponsor's protocol ID
- FWF_KLP9628023
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
Publications
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.
PubMed 38724880Bertinat 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.
PubMed 35074481Blauensteiner 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.
PubMed 34011981
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction in Post-infection Fatigue Syndromes
- ClinicalTrials.gov ID
- NCT06463106
- Acronym / sponsor ID
- FWF_KLP9628023
- Conditions
- Chronic Fatigue Syndrome, Long COVID
- Keywords
- ME/CFS, Long COVID, Endothelial dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- FH Joanneum Gesellschaft mbHIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (1 listed)
- The inclusion criteria for ME/CFS patients not infected with SARS-CoV-2 (n=17; females: 70.59%; age (years): 40.10 ± 10.80) and Long-Covid patients (n=30; females: 73.4%; age (years): 37.70 ± 9.96) include profound fatigue and at least one of the following symptoms: PEM, autonomic dysfunction, and/or orthostatic intolerance. All participants were included only if they were at least 12 weeks past an acute EBV infection and/or 10 weeks past an acute SARS-CoV-2 infection, respectively. SARS-CoV-2 specific IgA (A) and IgG (B) antibody titers were measured using commercial test kits (Anti-SARS-CoV-2-ELISA (IgA) and Anti-SARS-CoV-2-QuantiVac-ELISA (IgG); Euroimmun, Germany) in plasma samples.
Key exclusion criteria (1 listed)
- Participants' exclusion criteria included evidence of acute malignant diseases, diabetes mellitus, acute sepsis, chronic inflammatory gastrointestinal diseases, and frequent intake of analgesics, antacids, or antibiotics. Furthermore, no previously hospitalized SARS-CoV-2 patients were included, eliminating false-positive fatigue due to intensive care treatment, such as artificial respiration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Circulating levels of L-arginine metabolites
Time frame: 6 months
Ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS)
Markers of endothelial inflammation
Time frame: 6 months
ELISA
Production of reactive oxygen species (ROS) in endothelial cells
Time frame: 6 months
Fluorometric assay
Endothelial permeability
Time frame: 6 months
3D culture model
Angiogenesis
Time frame: 6 months
3D culture model
Epigenetic and transcriptomic patterns in endothelial cells
Time frame: 6 months
Genome wide DNA methylation and RNA sequencing (RNA-seq)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Background: PubMed 38724880Pipper 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.
- Background: PubMed 35074481Bertinat 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.
- Background: PubMed 34011981Blauensteiner 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.
- FWF / Austrian Science FundLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Fatigue Syndrome and Long COVID, run by FH Joanneum Gesellschaft mbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating levels of L-arginine metabolites (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06463106, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.