NCT04461834

Brief Summary

The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure Measurement App with and without initial calibration. Additionally, accuracy of the Blood Pressure Measurement 24 hours after calibration will also be tested.

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 all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

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, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2020

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

July 2, 2020

Last Update Submit

September 29, 2020

Conditions

Keywords

Blood PressureRIVA

Outcome Measures

Primary Outcomes (1)

  • Data statistical analysis

    Both Blood Pressure Measurement procedures are analysed for correlation and accuracy

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

AIl patients undergoing a 24h-ambulatory blood pressure measurement are eligible.

You may qualify if:

  • All patients undergoing a 24h-ambulatory blood pressure measurement

You may not qualify if:

  • age \< 18 years
  • impossibility to sign informed consent
  • physical restrictions to Blood Pressure Measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Basel

Basel, 4031, Switzerland

Location

Study Officials

  • Michael Mayr, PD Dr.

    University Hospital of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 8, 2020

Study Start

June 25, 2020

Primary Completion

September 24, 2020

Study Completion

September 24, 2020

Last Updated

October 1, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations