Clinical trial NCT05782647: Wearable Monitor in Patients With Syncope
Official title: Feasibility of Blood Pressure Measurement With a Wearable (Watch-type) Monitor in Patients With Syncope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope, Vasovagal
Keywords: Syncope
tilt testing
blood pressure monitoring
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cuffless (watch type) BP monitor and standard beat-to-beat monitoring device
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients,
* \>18 years of age, referred for tilt testing because affected by suspected reflex syncope

Exclusion Criteria:

* Arrhythmias or the inability of HeartGuide to measure BP supine at rest.

Primary outcomes:
measure: BP during event during tilt testing
timeFrame: 2 hours
Secondary outcomes:
measure: Compliance
timeFrame: 2 hours
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Auxologico Italiano
state: MI
Study officials:
References: