CRI in POTS in Adolescents

Completed

Conditions studied: Postural Orthostatic Tachycardia Syndrome

In brief

The investigators aim to study whether the Compensatory Reserve Index (CRI) (an FDA approved device that assesses intravascular volume) can be used to evaluate severity of Postural Orthostatic Tachycardia Syndrome (POTS) and whether the CRI value has a correlation with severity of psychosocial symptoms and functional impairment associated with POTS.

Key facts

Study ID

NCT03974737

Run by

University of Colorado, Denver

People needed

77

Starts

2019-06-01

Expected to finish

2020-09-22

Last updated by the study team

2021-01-26

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adolescent participants must be aged 12 to 21 years (inclusive).
• Each participant must have at one parent/legal guardian who can provide informed consent for the adolescent and participate in the study by completing study questionnaires.
• Moreover, as the majority of study measures are only validated for use in English, only English-speaking patients will be included in this study.

You may not qualify if…

• Adolescents will be excluded from the study if they are outside the age range of 12-21 years old
• Adolescents who are wards of the state
• Adolescents who are incarcerated
• Adolescents who are decisionally impaired (i.e., have difficulty understanding the protocol during the consent process, and/or research team member is unsure of individual's ability to correctly identify whether the research study would need to stop or not)
• Adolescents who object at any time to participating in the study
• Adolescents who have a pacemaker
• Adolescents who are taking beta blocker medications
• Adolescents who were were hospitalized in the past month for serious medical conditions affecting their cardiopulmonary system (note, this does not include recent hospitalizations for trauma or burns).
• Adolescents will also be excluded if their parent/legal guardian(s) are unwilling to participate in the study and/or do not have legal custody of the adolescent participant.
• Adolescents who do not speak English will be excluded from the study as majority of the study measures are only validated in English.

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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