Watch-VD: Wearable Monitor in Patients With Syncope

Sponsor

Istituto Auxologico Italiano (Other)

Overall Status

Completed

CT.gov ID

NCT05782647

Collaborator

(none)

Enrollment

Location

Arms

13.2

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Syncope, Vasovagal	Device: HeartGuide cuffless BP monitor	N/A

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).

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cuffless (watch type) BP monitor and standard beat-to-beat monitoring deviceCuffless (watch type) BP monitor and standard beat-to-beat monitoring device

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 25, 2021

Actual Primary Completion Date :

Jan 31, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cuffless BP monitoring Investigational device Omron HeartGuide® 6410T	Device: HeartGuide cuffless BP monitor Wearable (watch-type) monitor: HeartGuide 6410T (Omron Healthcare, Kyoto, Japan)
Active Comparator: Beat-to-beat BP monitoring 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)

Arm

Intervention/Treatment

Experimental: Cuffless BP monitoring

Investigational device Omron HeartGuide® 6410T

Device: HeartGuide cuffless BP monitor

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

Active Comparator: Beat-to-beat BP monitoring

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)

Outcome Measures

Primary Outcome Measures

BP during event during tilt testing [2 hours]
Difference between baseline (rest) BP and BP at the presyncopal event ("Delta BP slope") during tilt testing with HeartGuide and with control

Secondary Outcome Measures

Compliance [2 hours]
Number of patients who will show failure of HeartGuide to measure BP during tilt event

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Istituto Auxologico Italiano	Milan	MI	Italy	16149

Sponsors and Collaborators

Istituto Auxologico Italiano

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michele Brignole, Principal Investigator, Istituto Auxologico Italiano

ClinicalTrials.gov Identifier:

NCT05782647

Other Study ID Numbers:

09C128

First Posted:

Mar 23, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Michele Brignole, Principal Investigator, Istituto Auxologico Italiano

Syncope

tilt testing

blood pressure monitoring

Additional relevant MeSH terms:

Syncope

Syncope, Vasovagal

Study Results

No Results Posted as of Mar 27, 2023