UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053140 |
|---|---|
| Receipt number | R000060646 |
| Scientific Title | Investigation of Atrial Fibrillation Incidence in Hypertensive Patients |
| Date of disclosure of the study information | 2023/12/18 |
| Last modified on | 2024/12/19 14:59:52 |
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Basic information
Public title
Incidence of Atrial Fibrillation in Hypertensive Patients and Development of Risk Factor Management Methods to Prevent the Atrial Fibrillation
Acronym
Investigation of Atrial Fibrillation Incidence in Hypertensive Patients
Scientific Title
Investigation of Atrial Fibrillation Incidence in Hypertensive Patients
Scientific Title:Acronym
Investigation of Atrial Fibrillation Incidence in Hypertensive Patients
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to understand the incidence of new onset of atrial fibrillation in hypertensive patients and to develop a risk factor management method utilizing PHR.
Basic objectives2
Others
Basic objectives -Others
Identification of risk factors and development of an AI model for the prevention of atrial fibrillation and its management
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of new atrial fibrillation in hypertensive patients over 60 years of age by continuous electrocardiographic recordings over a 3-month period.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with a history of hypertension and taking antihypertensive medication
(2) Patients 60 years of age or older
(3) Patients with consent
Key exclusion criteria
(1) Patients currently participating or planning to participate in an interventional trial
(2) Patients with a confirmed diagnosis of atrial fibrillation (self-reported)
(3) Patients on anticoagulants (self-reported)
(4) Patients with an implanted pacemaker or defibrillator
(5) Patients residing outside Japan
(6) Patients who are judged to be inappropriate to participate in the study by the physician in charge
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Keitaro |
| Middle name | |
| Last name | Senoo |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Cardiac Arrhythmia Research and Innovation
Zip code
602-8566
Address
465 Kajiichou, Hirokouji, Kawaramachi, Kamigyo-ku, Kyoto
TEL
08031117168
k-senoo@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | Senoo |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Cardiac Arrhythmia Research and Innovation
Zip code
602-8566
Address
465 Kajiichou, Hirokouji, Kawaramachi, Kamigyo-ku, Kyoto
TEL
0752515511
Homepage URL
k-senoo@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Omron healthcare company
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
IRB center Kyoto Prefectural University of Medicine
Address
465 Kajiichou, Hirokouji, Kawaramachi, Kamigyo-ku, Kyoto
Tel
0752515337
rinri@koto.kpu-m.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 | 18 | Day |
Related information
URL releasing protocol
https://www.thieme-connect.com/products/ejournals/abstract/10.1055/a-2484-0641
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.com/products/ejournals/abstract/10.1055/a-2484-0641
Number of participants that the trial has enrolled
4000
Results
After excluding those with no measurement data (n = 258), AF detection was 5.8% (n = 220/3,820), and the time to AF detection was 3 to 109 days (median 28 days).
Results date posted
| 2024 | Year | 12 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Between April 2022 and July 2023, 4,078 hypertensive patients taking antihypertensive medications from across the country participated in this study (Figure S1). The baseline characteristics of the overall participants are summarized in Table 1. The mean age was 66.3years, and the proportion of men was 80.3%. As the mean BMI was 24.6, the proportion of metabolic syndrome was 31.8%. The median CHA2DS2-VASc score was 2.1. Among them, 258 patients were identified to have registered but never had a measurement record after the registration. Of the remaining 3,820, 225 had no morning or evening BP measurements and 25 had AF detected during the first 7-day period. Excluding those participants, the distribution of the systolic BP (SBP) and diastolic BP (DBP) at baseline for 3,570 participants are described in Figure.
Participant flow
The study was a DCT and the enrolment procedure is described below. During the enrolment period, to recruit participants, in-up messages (invitations to participate in the study) were distributed within the app to app users registered on the Omron Connect app (https://www.healthcare.omron.co.jp/service/, Omron Healthcare Corporation, Kyoto, Japan). The Omron Connect app is a health management app provided by Omron Healthcare. It allows users to easily transfer and manage data acquired by the company's blood pressure (BP) monitors, body composition analysers, and pedometers via Bluetooth communication on their smartphones. Because targeting only users of the Omron Connect app might preferentially include patients with easy access to high-tech technology, volunteers over 60 years old who were not users of the Omron Connect app were also recruited via the website. Participants reviewed the study outline and implementation details on the guidance website. Those wishing to participate were transferred from the information website to the application website. Within that site, participants were assessed for their eligibility for the study. Participants who were judged eligible reviewed the explanatory document on the website and obtained consent on the website. The research office sent the Complete by post in the order of the participants who completed the enrolment. After receiving the device, the participants were asked to record their electrocardiogram and BP for three months.
Adverse events
NA
Outcome measures
screening-detected AF during the 3 months.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
sub analysis underway.
Management information
Registered date
| 2023 | Year | 12 | Month | 18 | Day |
Last modified on
| 2024 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060646
