Evaluation of the accuracy of the blood pressure values measured by pressurized and decompressed oscillometric devices in hypertensive patients with specific complications

Evaluation of the accuracy of the blood pressure values measured by pressurized and decompressed oscillometric devices in hypertensive patients with specific complications - Evaluation of the accuracy of the blood pressure values measured by pressurized and decompressed oscillometric devices in hypertensive patients with specific complications

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000053071

Enrollment

200

Registered

2023-12-14

Start date

2023-12-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, diabetes, chronic kidney disease (CKD), heart failure, history of atherosclerotic cardiovascular disease (ASCVD: stroke, myocardial infarction, angina pectoris, aortic dissection, peripheral vascular disease)

Interventions

Blood pressure measurements are taken 14 times in the sitting position, up to a maximum of 20 times. The measurement procedure consists of two auscultation measurements, followed by three sets of tes

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all the following criteria will be eligible for this study. 1) Upper arm circumference: 22.0-42.0cm 2) Age at the time of consent >= 20 years old 3) Consent to participate in this study was obtained [Composition of subjects] 1) At least 40 subjects aged 65 years and over 2) At least 40 hypertensive patients each with the following complications: diabetes*1, CKD*2, heart failure, history of ASCVD (however, patients with multiple complications may be enrolled, in which case they will be included in the number of patients with each disease). 3) At least 40 hypertensive patients without any complications of the diseases listed in 2) *1: HbA1c >= 6.5 % or medicated diabetes mellitus *2: eGFR < 60 mL/min/1.73 m2 or urinary protein (+) or higher

Exclusion criteria

Exclusion criteria: Patients with upper arm injuries that cannot be worn with a cuff Patients with arrhythmia Pregnant women

Design outcomes

Primary

Measure	Time frame
Consistency of the blood pressure values measured by a pressurized or decompressed oscillometric BP monitoring device and by an auscultatory method	—

Secondary

Measure	Time frame
- Systolic BP and diastolic BP in each method - Measurement error relative to reference (auscultation value) - Measurement error relative to reference (auscultation value) in each disease group - BP waveforms and shapes in each disease group	—

Countries

Japan

Contacts

Public ContactKazuomi Kario

Jichi Medical University School of Medicine Division of Cardiovascular, Medicine, Department of Medicine

kkario@jichi.ac.jp0285-58-7538

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026