NCT05782647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

March 11, 2023

Last Update Submit

February 16, 2024

Conditions

Syncope, Vasovagal

Keywords

Syncopetilt testingblood pressure monitoring

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Compliance

    2 hours

Study Arms (2)

Cuffless BP monitoring

EXPERIMENTAL

Investigational device Omron HeartGuide® 6410T

Device: HeartGuide cuffless BP monitor

Beat-to-beat BP monitoring

ACTIVE COMPARATOR

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

Interventions

HeartGuide cuffless BP monitorDEVICE

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

Beat-to-beat BP monitoringCuffless BP monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Auxologico Italiano

Milan, MI, 16149, Italy

Location

MeSH Terms

Conditions

Syncope, VasovagalSyncope

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Cuffless (watch type) BP monitor and standard beat-to-beat monitoring device
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2023

First Posted

March 23, 2023

Study Start

May 25, 2021

Primary Completion

January 31, 2022

Study Completion

June 30, 2022

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

Data will be available upon reasonable request to the principal investigator

Shared Documents
CSR
Time Frame
Aafter publication of the princiapl study
Access Criteria
m.brignole@auxologico.it

Locations

IT(1)