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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05782699
Other study ID # 09C126
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 25, 2021
Est. completion date May 31, 2022

Study information

Verified date March 2023
Source Istituto Auxologico Italiano
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 cuffless patch 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 between BP measured by mean of a cuffless patch BP monitor (RootiRX System, Rooti Labs Ltd., Taipei, Taiwan) and by mean of the standard method during tilt testing. Study design BP values observed during tilt testing baseline and at the time of impeding syncope will be measured by mean of the RootiRX device and will be compared with the standard of reference. BP will be recorded at rest at baseline, shortly after upright in tilting position (at stabilization), at the time of occurrence of 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 50
Est. completion date May 31, 2022
Est. primary completion date May 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: - Incapability to perform tilt testing

Study Design


Related Conditions & MeSH terms


Intervention

Device:
BP monitoring during tilt testing
BP measure at various times during tilt testing

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 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 BP drop Absolute BP values during tilt event with RootiRx and with Finometer 2 hours
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