This trial is active, not recruiting.

Conditions hypertension, blood pressure
Treatments cuff device (omron hbp-1300-e pro), iphone 4s
Sponsor Jens Eckstein
Collaborator Preventicus GmbH
Start date October 2015
End date April 2016
Trial size 1019 participants
Trial identifier NCT02552030, EKNZ 2015-287


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
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)'
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
iphone 4s

Primary Outcomes

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

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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - able to give informed consent - in Sinus rhythm - no anatomical limitation to take blood pressure Exclusion Criteria: - Atrial fibrillation - Dialysis shunt

Additional Information

Official title iPhone App Compared to Standard RR-measurement - iPARR Trial
Principal investigator Jens Eckstein, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University Hospital, Basel, Switzerland.