A Study to Evaluate Remote Wearable-based Diagnosis of Postural Orthostatic Tachycardia Syndrome

Overview

About this study

The purpose of this study is to test the feasibility of using a novel wearable biosensor and mobile health monitoring platform to capture patients’ physiology, functional capacity and assessment of symptoms, thereby building a profile of Positional Orthostatic Tachycardia Syndrome (POTS) while excluding more serious cardiac, neurological and endocrine causes for their symptomatology. We hypothesize that as a non-fatal condition, a complete physiological profile of the POTS patients can be built entirely remotely therefore avoiding the need for these patients to visit the hospital and clinic.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - POTS Confirmed Subjects:

Postural Orthostatic Tachycardia Syndrome (POTS) confirmed subjects are eligible to be included in the study only if all of the following criteria apply:

  • Presumed diagnosis of POTS and planned for evaluation and confirmatory testing in the Mayo Clinic POTS Innovation program.
  • Subjects has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age ≥ 18 to ≤ 40 years at signing of informed consent.

Inclusion Criteria - Control Subjects:

  • No diagnosis of POTS or suspicion for POTS.
  • Subjects has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age ≥ 18 to ≤ 40 years at signing of informed consent.

Exclusion Criteria:

All subjects are excluded from the study if any of the following criteria apply:

  • Refusal to sign informed consent.
  • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the subject and investigator’s knowledge.
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Christopher McLeod, M.B., Ch.B., Ph.D.

Closed for enrollment

Contact information:

Erika Douglass M.P.H.

(904) 953-6595

Douglass.Erika@mayo.edu

More information

Publications

Publications are currently not available
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