ViTrack: Wearable, accurate, continuous blood pressure monitor to improve outcomes in hypertensive diseases of pregnancy

Dynocardia, Inc., Newton Center MA

Investigators

Abstract

Dynocardia, a Tufts University School of Medicine and Massachusetts Institute of Technology spinoff, is addressing an unmet need for real-world accurate and continuous non-invasive blood pressure (BP) and other cardio-hemodynamic parameters. ViTrack™, a unique optomechanical sensor and computer vision technology, is the first to measure beat-to-beat systolic (SBP) and diastolic BPs (DBP) in real-world settings with the accuracy of invasive arterial pressure without external calibration, irrespective of subject movement or wrist position relative to the heart (hydrostatic pressure change). Dynocardia is expanding into the hospital market and exploring its technology's potential in other areas of healthcare, particularly in maternal health. Dynocardia has secured an SBIR Phase II grant [Project Number: 1R44HL167356-01] to study the effectiveness of ViTrack technology in ensuring the safety and well-being of mothers and their children during pregnancy. I. Project summary: ViTrack’s beat-to-beat accurate measurements, irrespective of patient movement or wrist level to the heart, provide the patient’s circadian BP pattern, including 24-hr mean BP, nighttime BP, and BP variability (BPV). In addition, ViTrack also measures heart rate, respiratory parameters, and advanced hemodynamics. The hypertensive diseases of pregnancy (HDP) are a significant cause of morbidity and mortality. The current standard for measuring BP in pregnant women is the periodic use of oscillometric arm-cuff devices. The oscillometric devices indirectly estimate SBP and DBP based on artery wall oscillations during cuff deflation. Measurement errors inherent to this indirect method, patient posture/movement, and wrong cuff size lead to unreliable BP measurements in 50% of routine office visits. Oscillometric device errors are compounded in pregnant women due to hemodynamic and vascular changes that reduce oscillations of the arterial wall, resulting in BP underestimation. In contrast, these hemodynamic changes will have less impact on ViTrack measurements because it utilizes pressure-dependent spatiotemporal skin displacement to measure SBP and DBP directly. In addition, random clinic measurements during antenatal visits lead to a 30% wrong diagnosis of HDP due to white coat or masked hypertension. In addition, there is a need for remote and continuous accurate measurement of BP for prediction and early deduction of preeclampsia. The circadian BP parameters, such as 24-hr mean SBP, nighttime BP, and BPV, are better predictors of preeclampsia than clinic BP measurements. ViTrack, the first standalone, wearable, connected device, can provide remote, accurate circadian BP data for correct diagnosis and enable predictive monitoring for better outcomes. In preclinical, outpatient [vs. auscultatory method], and inpatient [vs. invasive arterial pressure], ViTrack met FDA standards for accuracy. In this SBIR Phase II study, we are expanding the application of ViTrack in HDP in partnership with NYC Health + Hospitals that serves underserved populations, a large percentage of them non-Hispanic Black population at high risk for HDP. The Aims of the study are: Specific Aim (SA) 1: Assess the accuracy of ViTrack BP measurements (n=48). SA1(a): Determine the accuracy of ViTrack measurements in pregnant women (n=33) as per the European Society of Hypertension International Protocol-2010) [34]; SA1(b): Determine accuracy in severe preeclampsia (n=15), defined as BP measurement of 170/110 or more and proteinuria of 500 mg or more in 24-hr. Milestone: ViTrack accurately measures BP in pregnant women, including women with severe preeclampsia. SA2: Assessment of 24-hr BP with ViTrack (n=100). Collect 24-hr BP with ViTrack and intermittent cuff BP measurements as per standard practice from the contralateral arm; SA2(a): Assess tolerability/usability and reliability of 24-hr beat-to-beat BP in unconstrained subjects (n=20); SA2(b): Compare the 24-hr BP profile in pregnant women with and without HDP (n=80); SA2(c): Compare the number of hypotensive/hypertensive episodes with ViTrack continuous measurements vs. the intermittent cuff measurements. Milestone: ViTrack provides reliable 24-hr data despite patient movement. The data generated will validate ViTrack as the first standalone technology for accurate and continuous BP during pregnancy. This foundational data will inform the commercial build, final clinical validation and FDA submission, and 510(k) approval for continuous BP measurement in pregnant women. In addition, further randomized control trials will validate the application of ViTrack in risk prediction, early diagnosis, and management of preeclampsia and, thus, as the new standard of care for BP monitoring during pregnancy.