iPhone App Compared to Standard RR-measurement

NCT ID: NCT02552030

Last Updated: 2017-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1019 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Participants will be asked for consent at the University Hospital Basel at random based on availability. Recruitment is not limited to patients. After consenting patients will accompanied to a RR-measurement unit, positioned in a chair and kept at rest for 4 minutes. Then 7 blood pressure measurements at the same arm will be performed (Cuff/iPhone/Cuff/iPhone/Cuff/iPhone/Cuff). The Cuff measurement results will be documented in the source documents (mmHg) and transferred to a trial database. The iPhone data will be transferred with patient ID to "Preventicus" for calculation of the systolic blood pressure values (mmHg) based on the pulse waves recorded by transillumination of the index fingers of the participants. "Preventicus" will have NO access to the Cuff-measurement data. Then this data will be retransferred to the trial site and merged with help of the patient ID. Absolute and relative differences of the measured (Omron) and calculated (iPhone) systolic blood pressure values (mmHg) for will be calculated and published.

A subgroup of 40 participants will be evaluated in a highly standardized fashion according the ESH (European Society Hypertension) guidelines for validation studies. These data will then be published separately for validation purposes.

Conditions

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Hypertension Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Blood pressure-measurement

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)'

Group Type EXPERIMENTAL

cuff device (Omron HBP-1300-E Pro)

Intervention Type DEVICE

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

iPhone 4s

Intervention Type DEVICE

Interventions

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cuff device (Omron HBP-1300-E Pro)

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

Intervention Type DEVICE

iPhone 4s

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Atrial fibrillation
* Dialysis shunt
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Preventicus GmbH

INDUSTRY

Sponsor Role collaborator

Jens Eckstein

OTHER

Sponsor Role lead

Responsible Party

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Jens Eckstein

PD Dr. med, Leitender Arzt

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jens Eckstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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Universityhospital

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 33321118 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33319471 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30371728 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29632098 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29530989 (View on PubMed)

Related Links

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http://www.preventicus.com

Developer of the tested App and responsible for blinded analysis of the iPhone data

Other Identifiers

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EKNZ 2015-287

Identifier Type: -

Identifier Source: org_study_id

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