UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053071 |
|---|---|
| Receipt number | R000060557 |
| Scientific Title | Evaluation of the accuracy of the blood pressure values measured by pressurized and decompressed oscillometric devices in hypertensive patients with specific complications |
| Date of disclosure of the study information | 2023/12/14 |
| Last modified on | 2023/12/17 11:14:41 |
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Basic information
Public title
Evaluation of the accuracy of the blood pressure values measured by pressurized and decompressed oscillometric devices in hypertensive patients with specific complications
Acronym
Evaluation of the accuracy of the blood pressure values measured by pressurized and decompressed oscillometric devices in hypertensive patients with specific complications
Scientific Title
Evaluation of the accuracy of the blood pressure values measured by pressurized and decompressed oscillometric devices in hypertensive patients with specific complications
Scientific Title:Acronym
Evaluation of the accuracy of the blood pressure values measured by pressurized and decompressed oscillometric devices in hypertensive patients with specific complications
Region
| Japan |
Condition
Condition
Hypertension, diabetes, chronic kidney disease (CKD), heart failure, history of atherosclerotic cardiovascular disease (ASCVD: stroke, myocardial infarction, angina pectoris, aortic dissection, peripheral vascular disease)
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the consistency of the blood pressure values measured by a pressurized or decompressed oscillometric BP monitoring device and by an auscultatory method in hypertensive patients with and without specific complications
Basic objectives2
Others
Basic objectives -Others
Validation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Consistency of the blood pressure values measured by a pressurized or decompressed oscillometric BP monitoring device and by an auscultatory method
Key secondary outcomes
- 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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
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 test measurement performed in the following order: decompressed device, auscultatory measurement, pressurised device, and then auscultatory measurement OR pressurised device, auscultatory measurement, decompressed device, and then auscultatory measurement.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key exclusion criteria
Patients with upper arm injuries that cannot be worn with a cuff
Patients with arrhythmia
Pregnant women
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular, Medicine, Department of Medicine
Zip code
3290498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan
TEL
0285-58-7538
kkario@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular, Medicine, Department of Medicine
Zip code
3290498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan
TEL
0285-58-7538
Homepage URL
kkario@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Omron Healthcare
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Hospital Bioethics Committee for Clinical Research
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan
Tel
0285-58-8933
rinri@jichi.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060557
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