Viewing Study NCT06054958



Ignite Creation Date: 2024-05-06 @ 7:34 PM
Last Modification Date: 2024-10-26 @ 3:09 PM
Study NCT ID: NCT06054958
Status: COMPLETED
Last Update Posted: 2023-09-26
First Post: 2023-08-16

Brief Title: POTS-CFS Study Orthostatic Intolerance in the Context of Pediatric MECFS
Sponsor: Technical University of Munich
Organization: Technical University of Munich

Study Overview

Official Title: POTS-CFS Study A Case-Control Study on Exertion and Orthostatic Intolerance in the Context of Pediatric MECFS
Status: COMPLETED
Status Verified Date: 2023-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: POTS-CFS
Brief Summary: Pilot-case-control study on exertion and orthostatic intolerance of adolescents with myalgic encephalomyelitis chronic fatigue syndrome MECFS compared to age-matched healthy controls HC
Detailed Description: MECFS is a complex disease Symptoms include orthostatic intolerance OI such as postural tachycardia syndrome PoTS PoTS in MECFS 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 MECFS 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

MECFS 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 andor the pediatric case suggested by Jason 2006 Questionnaires were used to evaluate symptoms eg 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 8D892 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None