NCT03997461

Brief Summary

The study aims at comparing the values of the blood pressure measurements obtained during 24 hours by an arterial tonometry device (BPRo) and a standard oscillometric blood pressure monitoring device (Oscar 2) under ambulatory conditions

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

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

September 26, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

June 20, 2019

Last Update Submit

October 18, 2019

Conditions

Blood Pressure

Keywords

Blood Pressure

Outcome Measures

Primary Outcomes (2)

  • Difference in systolic blood pressure taken simultaneously by BPro and Oscar 2 devices

    Mean of the absolute differences in systolic blood pressure (mmHg) taken simultaneously by BPro and Oscar 2 devices at 15 minutes intervals during the day and 30 minutes intervals during the night for a period of 24 hours

    24 hours

  • Difference in diastolic blood pressure taken simultaneously by BPro and Oscar 2 devices

    Mean of the absolute differences in diastolic blood pressure (mmHg) taken simultaneously by BPro and Oscar 2 devices at 15 minutes intervals during the day and 30 minutes intervals during the night for a period of 24 hours

    24 hours

Study Arms (1)

BPro vs Oscar 2

EXPERIMENTAL

Blood pressure measurement with BPro and Oscar 2 simultaneously during 24 hours under ambulatory conditions

Device: BPro

Interventions

BProDEVICE

BPro and Oscar 2 comparison for 24 hours

BPro vs Oscar 2

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give informed consent

You may not qualify if:

  • Difference in blood pressure between the arms higher than 10 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Biological and Medical Engineering

Santiago, Santiago Metropolitan, 7820436, Chile

Location

Study Officials

  • Maria Rodriguez Fernandez, PhD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2019

First Posted

June 25, 2019

Study Start

September 26, 2018

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)