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

Technical University of Munich

Status: Completed

Conditions: Orthostatic Intolerance; Postural Orthostatic Tachycardia Syndrome; Chronic Fatigue Syndrome in Adolescence

Study type: Observational

Funder types: Other

Identifiers

NCT06054958

POTS-CFS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 14 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

ME/CFS

Description:

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)

Description:

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.