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POTS-CFS Study: Orthostatic Intolerance in the Context of Pediatric ME/CFS (POTS-CFS)

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ClinicalTrials.gov Identifier: NCT06054958
Recruitment Status : Completed
First Posted : September 26, 2023
Last Update Posted : September 26, 2023
Sponsor:
Collaborator:
University Hospital, Aachen
Information provided by (Responsible Party):
Technical University of Munich

Study Description
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Brief Summary:
Pilot-case-control study on exertion and orthostatic intolerance of adolescents with myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS) compared to age-matched healthy controls (HC).

Condition or disease
Chronic Fatigue Syndrome in Adolescence Postural Orthostatic Tachycardia Syndrome Orthostatic Intolerance

Detailed Description:

ME/CFS is a complex disease. Symptoms include orthostatic intolerance (OI) such as postural tachycardia syndrome (PoTS). PoTS in ME/CFS can significantly impair everyday function and social participation. Yet, data in affected adolescents are rare and inconsistent.

This pilot-case-control study study aimed at characterizing OI in adolescents aged 14-17 years with ME/CFS and age-adapted HC, comparing the results with other clinical features of both such as exertion intolerance, fatigue, and health-related quality of life, and suggesting a standardized tool for diagnostics.

ME/CFS was diagnosed according to the Clinical Canadian Criteria (CCC 2003), criteria of the former Institute of Medicine (IOM 2015), the diagnostic work sheet developed by Rowe 2017, and/or the pediatric case suggested by Jason 2006. Questionnaires were used to evaluate symptoms (e.g. post-exertional malaise, fatigue, anxiety, depression), and health-related quality of life. A standardized specific interview was performed to assess the medical history of OI (HOI). Heart rate (HR) and blood pressure were evaluated every minute during a passive 10-min standing test (NASA lean test) in the morning with empty stomach and without morning medication.

Data were evaluated according to the PoTS criteria defined in 2019 at the National Institutes of Health Expert Consensus Meeting and by the International Classification of Diseases (ICD-11) (8D89.2). Frequency and type of OI, including PoTS, were examined in both groups and outcomes compared to parameters from questionnaires. Based on the results, novel standards for OI diagnostics were suggested.

Study Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: POTS-CFS Study: A Case-Control Study on Exertion and Orthostatic Intolerance in the Context of Pediatric ME/CFS
Actual Study Start Date : December 6, 2021
Actual Primary Completion Date : November 22, 2022
Actual Study Completion Date : November 22, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
ME/CFS

ME/CFS: adolescents aged 14-17 years, fulfilling diagnostic criteria for ME/CFS according to Rowe e 2017, Jason 2006, CCC 2003, and/ or IOM 2015 at the time of recruitment.

Methods: Semi-structured interview, questionnaires, passive 10-minute standing test (NASA lean test), blood sampling.
Healthy Controls (HC)

HC: adolescents aged 14-17, clinically healthy without any known underlying disease and with no prescription drugs (except contraception).

Methods: Semi-structured interview, questionnaires, passive 10-minute standing test (NASA lean test), blood sampling.


Outcome Measures
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Primary Outcome Measures :
  1. Heart Rate during Passive 10-min. standing test [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    Heart rate during Passive 10-Min. standing test (NASA lean test)

  2. Blood Pressure during Passive 10-min. standing test [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    blood pressure, pulse pressure (calculated by systolic and diastolic blood pressure) during Passive 10-Min. standing test (NASA lean test)

  3. Symptoms during Passive 10-Min. standing test [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    Symptoms during Passive 10-Min. standing test (NASA lean test): Yes/No

  4. O2-Saturation during Passive 10-Min. standing test [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    O2-Saturation during Passive 10-Min. standing test (NASA lean test)

  5. Presence of Orthostatic Intolerance: Semistructured Interview [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    Semistructured Interview, History of Orthostatic Intolerance (OI): Yes/No

  6. Number of orthostatic Symptoms: Semistructured Interview [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    Semistructured Interview, Number of Symptoms

  7. Number of participants with a diagnosis of PoTS, Orthostatic Intolerance and related diagnoses [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    History of OI and Nasa lean test together result in an orthostatic diagnosis, Fulfilling of PoTS-Criteria at study visit is evaluated

  8. Presence of ME/CFS-specific Symptoms (Munich Berlin Symptom Questionnaire) [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    Questionnaire: number of relevant symptoms. Likert Scale "0-4" of severity and frequency for each symptom: A symptom is relevant with a severity and frequency of each at least "2" on the Likert Scale. Minimum: 0 relevant symptoms (best), Maximum: 60 relevant symptoms (worst).

  9. Presence of Post-exertional malaise (DePaul Symptom Questionnaire -Post exertional Malaise: DSQ-PEM) [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    Questionnaire, Binary Outcome: Post-exertional Malaise Yes/No

  10. Self-estimated level of Quality of Life: EQ-5D-5L: Index [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    Questionnaire: Index (0 worst - 1 best)

  11. Self-estimated level of Quality of Life: EQ-5D-5L: Visual Analog Scale [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    Visual Analog Scale (0 worst - 100 best)

  12. Screening via Public Health Questionnaire-4 (PHQ-4) [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    Ultra-Short-4-item-Screening for Anxiety/Depression: Scale (0 Symptom occurs never - 3 Symptom occurs almost every day)

  13. Malmö PoTS Score (MAPS) [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    Orthostatic Symptoms Severity, Scale (0 no symptom burden - 120 highest symptom burden)


Secondary Outcome Measures :
  1. Levels of serum antibodies against EBV [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    Levels of Autoantibodies at study visit

  2. Levels of serum antibodies against SARS-CoV-2 [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    Levels of autoantibodies at study visit

  3. Levels of serum autoantibodies [ Time Frame: one time point during study from study start until study completion, approximately 1 year ]
    Levels of autoantibodies at study visit


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adolescents with ME/CFS and healthy controls
Criteria

Inclusion Criteria:

  1. Cases (ME/CFS):

    - ME/CFS diagnosed by the indicated clinical criteria

  2. Healthy Controls

    • clinically healthy
    • no known underlying disease
    • no prescription medication (except contraception)

Exclusion Criteria:

  • Any contraindication for NASA lean test (cardiac failure, severe aortic stenosis, inability to stand)
  • pregnancy
  • breastfeeding.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06054958


Locations
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Germany
MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital Munich
Munich, Bavaria, Germany, 80804
Sponsors and Collaborators
Technical University of Munich
University Hospital, Aachen
More Information
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Additional Information:

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Responsible Party: Technical University of Munich
ClinicalTrials.gov Identifier: NCT06054958    
Other Study ID Numbers: POTS-CFS
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Postural Orthostatic Tachycardia Syndrome
Orthostatic Intolerance
Tachycardia
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
 Cardiac Conduction System Disease
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Neuroinflammatory Diseases
Nervous System Diseases
Neuromuscular Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Neurologic Manifestations