Status:
COMPLETED
POTS-CFS Study: Orthostatic Intolerance in the Context of Pediatric ME/CFS
Lead Sponsor:
Technical University of Munich
Collaborating Sponsors:
University Hospital, Aachen
Conditions:
Chronic Fatigue Syndrome in Adolescence
Postural Orthostatic Tachycardia Syndrome
Eligibility:
All Genders
14-17 years
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 participat...
Eligibility Criteria
Inclusion
- Cases (ME/CFS):
- \- ME/CFS diagnosed by the indicated clinical criteria
- Healthy Controls
- clinically healthy
- no known underlying disease
- no prescription medication (except contraception)
Exclusion
- Any contraindication for NASA lean test (cardiac failure, severe aortic stenosis, inability to stand)
- pregnancy
- breastfeeding.
Key Trial Info
Start Date :
December 6 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 22 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06054958
Start Date
December 6 2021
End Date
November 22 2022
Last Update
September 26 2023
Active Locations (1)
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1
MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital Munich
Munich, Bavaria, Germany, 80804