An interventional study of HeartGuide cuffless BP monitor in Syncope, Vasovagal, sponsored by Istituto Auxologico Italiano. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Istituto Auxologico Italiano · Not applicable, Interventional, and Diagnostic
The main purpose of this study is to assess the reliability of a new patient's self-administered wearable watch-type BP monitor in detecting episodes of hypotensive (pre)syncope. Secondary aim regards the estimation of feasibility of this tool.
Background While ECG monitoring is a reliable and established method that allows to document bradycardia in a substantial proportion of patients affected by cardioinhibitory reflex syncope, the documentation of a transient hypotension is only seldom achieved in patients affected by hypotensive syncope. Conventional ambulatory blood pressure (BP) monitoring (ABPM) has important limitations due to the short period of monitoring (usually 24-48 hours) and the intermittent nature of BP measurements (usually every 15-20 min).
The main purpose of this study is to assess the reliability of a new patient's self-administered wearable watch-type BP monitor in detecting episodes of hypotensive (pre)syncope. Secondary aim regards the estimation of feasibility of this tool.
Method The study is a prospective intrapatient comparison during tilt testing between BP measured by mean of a wearable watch-type BP monitor (Omron HeartGuide 6410T, Omron Healthcare, Kyoto, Japan) and by mean of the standard methods for continuous finger BP monitoring (Finometer®, Finapres Medical Systems, Enchede, The Netherlands, and Task Force® monitor, CNSystem, Graz, Austria), based on the photoplethysmographic volume clamp method .
Study design BP values observed during tilt testing baseline and at the time of impeding syncope will be measured by mean of the HeartGuide device and will be compared with the standard of reference of BP. BP will be recorded at rest at baseline, shortly after upright in tilting position (at stabilization), at the time of occurrence of impeding syncope (presyncope) or, alternatively at the time of maximum hypotensive effect, if syncope will not occur, and finally in the recovery period at the end of the test after returning in supine position.
226 studies on the registry are indexed under Syncope; 45 are open to participants now.
This study's enrollment of 81 is close to the median of 79 across 126 interventional studies indexed under Syncope.
Browse Syncope studies →Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.
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Exclusion Criteria:
Investigational device Omron HeartGuide® 6410T
Device: HeartGuide cuffless BP monitor
Continuous finger BP monitoring (Finometer®, Finapres Medical Systems, Enchede, The Netherlands, and Task Force® monitor, CNSystem, Graz, Austria), based on the photoplethysmographic volume clamp method
Device: HeartGuide cuffless BP monitor
Wearable (watch-type) monitor: HeartGuide 6410T (Omron Healthcare, Kyoto, Japan)
BP during event during tilt testing
Difference between baseline (rest) BP and BP at the presyncopal event ("Delta BP slope") during tilt testing with HeartGuide and with control
Time frame: 2 hours
Compliance
Number of patients who will show failure of HeartGuide to measure BP during tilt event
Time frame: 2 hours
Plan to share: Yes — Data will be available upon reasonable request to the principal investigator
Supporting information: Csr
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Istituto Auxologico Italiano