臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 22, 2023
Last modified on	Dec. 22, 2023
Trial ID	jRCT1052230151

Scientific Title	Incidence of Atrial Fibrillation in Hypertensive Patients and Development of Risk Factor Management Methods to Prevent Atrial Fibrillation
Public Title	Investigation of Atrial Fibrillation Incidence in Hypertensive Patients

Contact for Scientific Queries	Name	Keitaro Senoo
	Affiliation	Kyoto Prefectural University of Medicine, Department of Cardiac Arrhythmia Research and Innovation
	Address	Kamigyo-ku Kajii-cho 465, Kawaramachi-Hirokoji
	Telephone	+81-8031117168
	E-mail	k-senoo@koto.kpu-m.ac.jp
Contact for Public Queries	Name	Keitaro Senoo
	Affiliation	Kyoto Prefectural University of Medicine, Department of Cardiac Arrhythmia Research and Innovation
	Address	Kamigyo-ku Kajii-cho 465, Kawaramachi-Hirokoji
	Telephone	+81-752515511
	E-mail	k-senoo@koto.kpu-m.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		April. 25, 2022
Actual date of first enrollment		April. 25, 2022
Target sample size		4000
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose	screening
Key inclusion & exclusion criteria	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
	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
	Age Minimum	60age old over
	Age Maximum	No limit
	Gender
Health Condition(s) or Problem(s) Studied		Hypertension
Intervention(s)
Health Condition(s) Keyword		hypertension, atrial fibrillation
Intervention(s) Keyword
Health Condition(s) Code		D006973
Intervention(s) Code
Primary Outcome(s)		Detection rate of new atrial fibrillation in hypertensive patients over 60 years of age by continuous electrocardiographic recordings over a 3-month period.
Secondary Outcome(s)		Detection rate of new atrial fibrillation by age Detection rate of new atrial fibrillation by blood pressure group Relationship between blood pressure and incidence of atrial fibrillation Identification of risk factors associated with new onset of atrial fibrillation in hypertensive patients Development of a model for the management of risk factors for the development of atrial fibrillation Cost-effectiveness analysis

Primary Sponsor	n/a

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	KPUM IRB
Address	Kajii cho, Kawaramachi, Hirokouji, Kamigyo ku, Kyoto, Kyoto
Telephone	+81-8031117168
E-Mail	k-senoo@koto.kpu-m.ac.jp
Approval Status	Approval
Date of approval	Mar. 31, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none