NCT02552030

Brief Summary

In this Trial we compare a new application (App) running on an iPhone (Apple inc., Model 4S) to determine systolic blood pressure (RR) and compare it to conventional oscillometric measurements using an Omron HBP-1300-E Pro device. We will include 1000 participants and perform seven repetitive blood pressure measurements (3 iPhone, 4 Omron) in each person. Primary parameter will be the absolute difference (Delta) between the correlating blood pressure measurements in mmHg.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,019

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Oct 2015

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

First Submitted

Initial submission to the registry

September 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

September 14, 2015

Last Update Submit

February 13, 2017

Conditions

HypertensionBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • Absolute difference between systolic blood pressure values determined with an oscillometric cuff device and an iPhone 4s (Delta mmHg)

    In each participant seven repetitive blood pressure measurements will be performed. Starting with a conventional cuff measurement followed by an iPhone measurement, followed by a conventional cuff measurement and so on. Then the absolute difference between each pair of successive measurements will be calculated. These differences will then be averaged and documented as primary result.

    1 day

Secondary Outcomes (3)

  • Relative difference between oscillometric blood pressure measurement and iPhone based blood pressure measurement

    1 day

  • Percent of invalid measurements

    1 day

  • Comparison of primary outcome in the subgroup of patients with atherosclerosis compared to the participants without arteriosclerosis.

    1 day

Study Arms (1)

Blood pressure-measurement

EXPERIMENTAL

Seven repetitive blood pressure measurements will be performed the left or right arm of all participants with an iPhone 4s and a conventional oscillometric device 'cuff device (Omron HBP-1300-E Pro)'

Device: cuff device (Omron HBP-1300-E Pro)Device: iPhone 4s

Interventions

cuff device (Omron HBP-1300-E Pro)DEVICE

Comparison of systolic blood pressure results measured with an oscillometric cuff device (Omron HBP-1300-E Pro) and iPhone 4s

Blood pressure-measurement
iPhone 4sDEVICE
Blood pressure-measurement

Eligibility Criteria

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

You may qualify if:

  • able to give informed consent
  • in Sinus rhythm
  • no anatomical limitation to take blood pressure

You may not qualify if:

  • Atrial fibrillation
  • Dialysis shunt

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universityhospital

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (5)

  • Dorr M, Weber S, Birkemeyer R, Leonardi L, Winterhalder C, Raichle CJ, Brasier N, Burkard T, Eckstein J. iPhone App compared with standard blood pressure measurement -The iPARR trial. Am Heart J. 2021 Mar;233:102-108. doi: 10.1016/j.ahj.2020.12.003. Epub 2020 Dec 13.

    PMID: 33321118DERIVED

  • Vischer AS, Socrates T, Winterhalder C, Eckstein J, Mayr M, Burkard T. How should we measure blood pressure? Implications of the fourth blood pressure measurement in office blood pressure. J Clin Hypertens (Greenwich). 2021 Jan;23(1):35-43. doi: 10.1111/jch.14130. Epub 2020 Dec 14.

    PMID: 33319471DERIVED

  • Vischer AS, Mayr M, Socrates T, Winterhalder C, Leonardi L, Eckstein J, Burkard T. Impact of Single-Occasion American vs. Canadian Office Blood Pressure Measurement Recommendations on Blood Pressure Classification. Am J Hypertens. 2019 Jan 15;32(2):143-145. doi: 10.1093/ajh/hpy159.

    PMID: 30371728DERIVED

  • Raichle CJ, Eckstein J, Lapaire O, Leonardi L, Brasier N, Vischer AS, Burkard T. Performance of a Blood Pressure Smartphone App in Pregnant Women: The iPARR Trial (iPhone App Compared With Standard RR Measurement). Hypertension. 2018 Jun;71(6):1164-1169. doi: 10.1161/HYPERTENSIONAHA.117.10647. Epub 2018 Apr 9.

    PMID: 29632098DERIVED

  • Burkard T, Mayr M, Winterhalder C, Leonardi L, Eckstein J, Vischer AS. Reliability of single office blood pressure measurements. Heart. 2018 Jul;104(14):1173-1179. doi: 10.1136/heartjnl-2017-312523. Epub 2018 Mar 12.

    PMID: 29530989DERIVED

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Jens Eckstein, MD, PhD

    University Hospital, Basel, Switzerland

    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 INVESTIGATOR
PI Title
PD Dr. med, Leitender Arzt

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 16, 2015

Study Start

October 1, 2015

Primary Completion

April 25, 2016

Study Completion

December 31, 2016

Last Updated

February 14, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)