Wearable Monitor in Patients With Syncope

Syncope, Vasovagal Clinical Trial

— Watch-VD  

Official title:

Feasibility of Blood Pressure Measurement With a Wearable (Watch-type) Monitor in Patients With Syncope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05782647
• Other study ID #: 09C128
• Status: Completed
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2024
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Syncope
• Syncope, Vasovagal

Intervention

Device:
• HeartGuide cuffless BP monitor
Wearable (watch-type) monitor: HeartGuide 6410T (Omron Healthcare, Kyoto, Japan)

Locations

Country	Name	City	State
Italy	IRCCS Istituto Auxologico Italiano	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 hours
Secondary	Compliance	Number of patients who will show failure of HeartGuide to measure BP during tilt event	2 hours