NCT05782699

Brief Summary

The main purpose of this study is to assess the reliability of a new cuffless patch BP monitor in detecting episodes of hypotensive (pre)syncope during tilt testing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 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

June 25, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
9 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

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

March 11, 2023

Last Update Submit

March 23, 2023

Conditions

Syncope, Vasovagal

Keywords

syncopetilt table testblood pressure monitoring

Outcome Measures

Primary Outcomes (1)

  • BP pattern

    Difference between baseline (rest) BP and BP at the (pre)syncopal event ("Delta BP slope") during tilt testing with RootiRx and with standard method

    2 hours

Secondary Outcomes (1)

  • BP drop

    2 hours

Study Arms (2)

patch monitoring

EXPERIMENTAL
Device: BP monitoring during tilt testing

standard BP monitoring

ACTIVE COMPARATOR
Device: BP monitoring during tilt testing

Interventions

BP monitoring during tilt testingDEVICE

BP measure at various times during tilt testing

patch monitoringstandard 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:

  • Incapability to perform tilt testing

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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 11, 2023

First Posted

March 23, 2023

Study Start

June 25, 2021

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR
Time Frame
Upon reasonable request after the publication of the principal study
Access Criteria
m.brignole@auxologico.it

Locations

IT(1)