POTS Stroke Volume

Hemodynamic Biomarkers for Postural Tachycardia Syndrome Using a Novel Continuous Beat-to-Beat Wearable Blood Pressure Monitor

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.

Study Overview

• Status: Not yet recruiting
• Conditions: POTS
• Intervention / Treatment: Device: ear blood pressure monitor

Detailed Description

Detailed Description:

Project Purpose: 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. The 2019 NIH POTS Consensus meeting stated the need for biomarkers that would i) provide physiologically-based diagnostic criteria; ii) be easily accessible and affordable; iii) reflect disease activity and response to treatment, and provide long-term outcome data; and iv) provide uniform phenotyping and a shared database for multicenter studies.

Current POTS heart rate (HR) diagnostic criteria may not reflect hemodynamic changes in daily life, and do not measure the underlining physiology, which is reduced stroke volume (SV) in most patients. Beat-to-beat blood pressure (BP) recordings with waveforms can derive SV. the investigators have developed an inexpensive, wearable, wireless, rechargeable, beat-to-beat BP monitor that sits behind the ear. It weighs 13 gm and samples the BP with high resolution waveforms. SV can be estimated from BP waveform shapes.

Research Objectives: the investigators hypothesize that SV 1) can be estimated from wearable BP monitors, and 2) will provide physiologic information for patients and physicians.

Aim 1: To determine the accuracy of stroke volume estimated from a novel wearable BP monitor compared to that estimated from cardiac MRI.

Aim 2: To determine whether stroke volume differs between healthy controls and POTS subjects during stand tests in the lab and at home Aim 3: To determine whether stroke volume correlates with heart rate at home Aim 4: To assess user satisfaction in a multicenter study.

Study Design & Methodology:

Aim 1: Noninvasive BP waveforms will be acquired from 30 patients undergoing cardiac MRI. to provide accurate SV estimates. BP waveforms will be digitized at 50 Hz and SV will be estimated from BP waveforms with both published equations using parameters of the waveforms and with de novo algorithms developed using Matlab machine learning regression algorithms.

Aim 2: SV and HR will be recorded after 10 min headup tilt and the stand test from 20 POTS patients and 20 healthy controls. The same parameters will be recorded at home after 10 min quiet standing. the investigators will compare the home stand test and lab tilt test and stand tests.

Aim 3: the investigators will have the 20 symptomatic POTS patients and 20 healthy controls from Aim 2 wear the novel monitor for 12 daytime hours. the investigators will test the hypothesis that stroke volumes are lower and heart rate higher in 10-minute segments in the morning after arising and better in mid afternoon.

Aim 4: Devices will be provided to 3 centers who will each enroll 5 POTS patients and 5 control subjects. The devices will be worn for 12 daytime hours and the data stored anonymously in the cloud. Patients and physicians will be surveyed for their impressions of wearability, esthetics, comfort, and ease of donning and doffing, as well as data handling and review. Investigators will be given access to the anonymized, searchable, explorable data set and a draft Ambulatory POTS Monitor report.

Anticipated Outcomes: This proposed work will provide an easily accessible, affordable platform for multicentre, physiologically-based studies of diagnosis, treatment, and long-term outcome. This will enable hemodynamic monitoring of POTS patients at home.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Sheldon, Professor; Phone Number: 4032208897; Email: sheldon@ucalgary.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Undergoing clinically indicated cardiac MRI

  • Between 18 and 80 years of age.
  • Able and willing to provide informed consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ear blood pressure monitor	Device: ear blood pressure monitor; The ear blood pressure monitor is a biometric monitoring device that collects blood pressure non-invasively from the ear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: cardiac MRI; stroke volume; wearable BP monitor
• Other Study ID Numbers: POTS SV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No