POTS Stroke Volume
Hemodynamic Biomarkers for Postural Tachycardia Syndrome Using a Novel Continuous Beat-to-Beat Wearable Blood Pressure Monitor
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
the investigators propose studies of a tiny, wearable, wireless, beat-to-beat blood pressure monitor that will be both a transformative research platform and an enabler of patient self-care in the diagnosis, investigation, and management of POTS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2022
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedDecember 19, 2024
May 1, 2024
7 months
November 1, 2022
December 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
the accuracy of stroke volume estimated from a novel wearable BP monitor compared to that estimated from cardiac MRI.
that stroke volume can be accurately estimated based on ambulatory blood pressure and heart rate sequences and will diagnose POTS in patients at home, reflect clinical status, and be suitable for multicenter studies.
10 minutes pre-intervention (Cardiac MRI)
the accuracy of stroke volume estimated from a novel wearable BP monitor compared to that estimated from cardiac MRI.
that stroke volume can be accurately estimated based on ambulatory blood pressure and heart rate sequences and will diagnose POTS in patients at home, reflect clinical status, and be suitable for multicenter studies.
10 minutes post-intervention( cardiac MRI)
Study Arms (1)
ear blood pressure monitor
OTHERInterventions
The ear blood pressure monitor is a biometric monitoring device that collects blood pressure non-invasively from the ear.
Eligibility Criteria
You may qualify if:
- Undergoing clinically indicated cardiac MRI
- Between 18 and 80 years of age.
- Able and willing to provide informed consent
You may not qualify if:
- Somatization or severe anxiety symptoms will be excluded
- Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies
- Unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2022
First Posted
April 3, 2023
Study Start
June 1, 2025
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
December 19, 2024
Record last verified: 2024-05