HypertensioniPARRNCT02552030

iPhone App Compared to Standard RR-measurement

A study testing cuff device (Omron HBP-1300-E Pro) and iPhone 4s in people with Hypertension and Blood Pressure, run by Jens Eckstein at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hypertension, Blood Pressure
What is being tested?: cuff device (Omron HBP-1300-E Pro) and iPhone 4s
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,019 participants
Where: 1 siteSwitzerland
Study dates: 1 Oct 2015to 31 Dec 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Atrial fibrillation
Dialysis shunt

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Universityhospital
Basel, Canton of Basel-City, 4031

Other trials in Switzerland

About this study

Official title: iPhone App Compared to Standard RR-measurement - iPARR Trial

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.

Read the detailed description

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: Hypertension, Blood Pressure
Being tested: cuff device (Omron HBP-1300-E Pro), iPhone 4s
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
iPhone 4sDevice

Study groups in NCT02552030
Study group	Role	What they receive
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)' Receives: Device: cuff device (Omron HBP-1300-E Pro); Device: iPhone 4s

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 day

Secondary outcomes (3)

Relative difference between oscillometric blood pressure measurement and iPhone based blood pressure measurement
Same as primary outcome, but calculation of delta (mmHg) and documentation as relative value (%) of the absolute systolic value.
Measured: 1 day
Percent of invalid measurements
Percent of measurements that cannot be used for analysis
Measured: 1 day
Comparison of primary outcome in the subgroup of patients with atherosclerosis compared to the participants without arteriosclerosis.
Quantitative differences between the accuracy of the iPhone measurements in the patients with known arteriosclerosis and the patients without arteriosclerosis
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201531 Dec 2016

First posted16 Sep 2015 (estimated)
Study start1 Oct 2015
Primary completion25 Apr 2016
Study completion31 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,019 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02552030
Sponsor's protocol ID: EKNZ 2015-287
Acronym: iPARR
Status last verified: Feb 2017
First submitted: 14 Sep 2015
Last updated: 14 Feb 2017
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 33321118
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.
PubMed 33319471
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.
PubMed 30371728
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.
PubMed 29632098
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.
PubMed 29530989

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: iPhone App Compared to Standard RR-measurement - iPARR Trial
ClinicalTrials.gov ID: NCT02552030
Acronym / sponsor ID: iPARR / EKNZ 2015-287
Conditions: Hypertension, Blood Pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,019 participants (actual)
Lead sponsor: Jens EcksteinUniversity, hospital or other
Collaborators: Preventicus GmbH
Study start: 1 Oct 2015 (actual)
Primary completion: 25 Apr 2016 (actual)
Study completion: 31 Dec 2016 (actual)
First posted: 16 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Blood pressure-measurement	Experimental	Device: cuff device (Omron HBP-1300-E Pro), Device: iPhone 4sSeven 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)'

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

Atrial fibrillation
Dialysis shunt

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Device	Blood pressure-measurement
iPhone 4s	Device	Blood pressure-measurement

Primary outcome

Absolute difference between systolic blood pressure values determined with an oscillometric cuff device and an iPhone 4s (Delta mmHg)
Time frame: 1 day
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.

3 secondary outcomes

Relative difference between oscillometric blood pressure measurement and iPhone based blood pressure measurement
Time frame: 1 day
Percent of invalid measurements
Time frame: 1 day
Comparison of primary outcome in the subgroup of patients with atherosclerosis compared to the participants without arteriosclerosis.
Time frame: 1 day

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
Derived from this study: PubMed 33321118Dorr 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.
Derived from this study: PubMed 33319471Vischer 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.
Derived from this study: PubMed 30371728Vischer 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.
Derived from this study: PubMed 29632098Raichle 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.
Derived from this study: PubMed 29530989Burkard 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.
Developer of the tested App and responsible for blinded analysis of the iPhone dataLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Hypertension

RecruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Active, not recruitingPhase 3
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Hypertension
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia
RecruitingPhase 3
An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension, Interstitial Lung Disease
RecruitingPhase 2
A Clinical Trial of NS-863 in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jens Eckstein, MD, PhD principal investigator

University Hospital, Basel, Switzerland

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing cuff device (Omron HBP-1300-E Pro) and iPhone 4s in people with Hypertension and Blood Pressure, run by Jens Eckstein at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute difference between systolic blood pressure values determined with an oscillometric cuff device and an iPhone 4s (Delta mmHg) (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02552030, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017; AzTrials last refreshed its copy on 28 Oct 2026.