Clinical trial NCT06054958: POTS-CFS Study: Orthostatic Intolerance in the Context of Pediatric ME/CFS
Official title: POTS-CFS Study: A Case-Control Study on Exertion and Orthostatic Intolerance in the Context of Pediatric ME/CFS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Fatigue Syndrome in Adolescence
Postural Orthostatic Tachycardia Syndrome
Orthostatic Intolerance
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: University Hospital, Aachen
First posted: 2023-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with ME/CFS and healthy controls

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).

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.

Eligibility 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.

Primary outcomes:
measure: Heart Rate during Passive 10-min. standing test
timeFrame: one time point during study from study start until study completion, approximately 1 year
measure: Blood Pressure during Passive 10-min. standing test
timeFrame: one time point during study from study start until study completion, approximately 1 year
measure: Symptoms during Passive 10-Min. standing test
timeFrame: one time point during study from study start until study completion, approximately 1 year
measure: O2-Saturation during Passive 10-Min. standing test
timeFrame: one time point during study from study start until study completion, approximately 1 year
measure: Presence of Orthostatic Intolerance: Semistructured Interview
timeFrame: one time point during study from study start until study completion, approximately 1 year
measure: Number of orthostatic Symptoms: Semistructured Interview
timeFrame: one time point during study from study start until study completion, approximately 1 year
measure: Number of participants with a diagnosis of PoTS, Orthostatic Intolerance and related diagnoses
timeFrame: one time point during study from study start until study completion, approximately 1 year
measure: Presence of ME/CFS-specific Symptoms (Munich Berlin Symptom Questionnaire)
timeFrame: one time point during study from study start until study completion, approximately 1 year
measure: Presence of Post-exertional malaise (DePaul Symptom Questionnaire -Post exertional Malaise: DSQ-PEM)
timeFrame: one time point during study from study start until study completion, approximately 1 year
measure: Self-estimated level of Quality of Life: EQ-5D-5L: Index
timeFrame: one time point during study from study start until study completion, approximately 1 year
measure: Self-estimated level of Quality of Life: EQ-5D-5L: Visual Analog Scale
timeFrame: one time point during study from study start until study completion, approximately 1 year
measure: Screening via Public Health Questionnaire-4 (PHQ-4)
timeFrame: one time point during study from study start until study completion, approximately 1 year
measure: Malmö PoTS Score (MAPS)
timeFrame: one time point during study from study start until study completion, approximately 1 year
Secondary outcomes:
measure: Levels of serum antibodies against EBV
timeFrame: one time point during study from study start until study completion, approximately 1 year
measure: Levels of serum antibodies against SARS-CoV-2
timeFrame: one time point during study from study start until study completion, approximately 1 year
measure: Levels of serum autoantibodies
timeFrame: one time point during study from study start until study completion, approximately 1 year
Other outcomes:
Locations:
city: Munich
country: Germany
facility: MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital Munich
state: Bavaria
Study officials:
References: