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

Postural Orthostatic Tachycardia Syndrome Clinical Trial

— POTS-CFS  

Official title:

POTS-CFS Study: A Case-Control Study on Exertion and Orthostatic Intolerance in the Context of Pediatric ME/CFS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06054958
• Other study ID #: POTS-CFS
• Status: Completed
• Start date: December 6, 2021
• Est. completion date: November 22, 2022

Study information

• Verified date: July 2023
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 22, 2022
• Est. primary completion date: November 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue Syndrome, Chronic
• Orthostatic Intolerance
• Postural Orthostatic Tachycardia Syndrome
• Syndrome
• Tachycardia

Locations

Country	Name	City	State
Germany	MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital Munich	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Technical University of Munich	University Hospital, Aachen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate during Passive 10-min. standing test	Heart rate during Passive 10-Min. standing test (NASA lean test)	one time point during study from study start until study completion, approximately 1 year
Primary	Blood Pressure during Passive 10-min. standing test	blood pressure, pulse pressure (calculated by systolic and diastolic blood pressure) during Passive 10-Min. standing test (NASA lean test)	one time point during study from study start until study completion, approximately 1 year
Primary	Symptoms during Passive 10-Min. standing test	Symptoms during Passive 10-Min. standing test (NASA lean test): Yes/No	one time point during study from study start until study completion, approximately 1 year
Primary	O2-Saturation during Passive 10-Min. standing test	O2-Saturation during Passive 10-Min. standing test (NASA lean test)	one time point during study from study start until study completion, approximately 1 year
Primary	Presence of Orthostatic Intolerance: Semistructured Interview	Semistructured Interview, History of Orthostatic Intolerance (OI): Yes/No	one time point during study from study start until study completion, approximately 1 year
Primary	Number of orthostatic Symptoms: Semistructured Interview	Semistructured Interview, Number of Symptoms	one time point during study from study start until study completion, approximately 1 year
Primary	Number of participants with a diagnosis of PoTS, Orthostatic Intolerance and related diagnoses	History of OI and Nasa lean test together result in an orthostatic diagnosis, Fulfilling of PoTS-Criteria at study visit is evaluated	one time point during study from study start until study completion, approximately 1 year
Primary	Presence of ME/CFS-specific Symptoms (Munich Berlin Symptom Questionnaire)	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).	one time point during study from study start until study completion, approximately 1 year
Primary	Presence of Post-exertional malaise (DePaul Symptom Questionnaire -Post exertional Malaise: DSQ-PEM)	Questionnaire, Binary Outcome: Post-exertional Malaise Yes/No	one time point during study from study start until study completion, approximately 1 year
Primary	Self-estimated level of Quality of Life: EQ-5D-5L: Index	Questionnaire: Index (0 worst - 1 best)	one time point during study from study start until study completion, approximately 1 year
Primary	Self-estimated level of Quality of Life: EQ-5D-5L: Visual Analog Scale	Visual Analog Scale (0 worst - 100 best)	one time point during study from study start until study completion, approximately 1 year
Primary	Screening via Public Health Questionnaire-4 (PHQ-4)	Ultra-Short-4-item-Screening for Anxiety/Depression: Scale (0 Symptom occurs never - 3 Symptom occurs almost every day)	one time point during study from study start until study completion, approximately 1 year
Primary	Malmö PoTS Score (MAPS)	Orthostatic Symptoms Severity, Scale (0 no symptom burden - 120 highest symptom burden)	one time point during study from study start until study completion, approximately 1 year
Secondary	Levels of serum antibodies against EBV	Levels of Autoantibodies at study visit	one time point during study from study start until study completion, approximately 1 year
Secondary	Levels of serum antibodies against SARS-CoV-2	Levels of autoantibodies at study visit	one time point during study from study start until study completion, approximately 1 year
Secondary	Levels of serum autoantibodies	Levels of autoantibodies at study visit	one time point during study from study start until study completion, approximately 1 year

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