臨床研究等提出・公開システム

Date of registration	April. 28, 2025
Last modified on	Oct. 03, 2025
Trial ID	jRCT1050250010

Scientific Title	A multicenter collaborative study to explore the effectiveness of HeartLogic in the management of heart failure
Public Title	HeartLogic study

Contact for Scientific Queries	Name	Oka Takafumi
	Affiliation	Osaka University Hospital
	Address	2-15 Yamadaoka, Suita, Osaka
	Telephone	+81-6-6879-3640
	E-mail	oka.takafumi.med@osaka-u.ac.jp
Contact for Public Queries	Name	Oka Takafumi
	Affiliation	Osaka University Hospital
	Address	2-15 Yamadaoka, Suita, Osaka
	Telephone	+81-6-6879-3640
	E-mail	oka.takafumi.med@osaka-u.ac.jp

Recruitment status	Not Recruiting


Anticipated date of first enrollment		April. 28, 2025
Target sample size		400
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	- The study subjects who do not refuse to participate in the study by disclosing information about the study on the website or posters of each collaborating institution as an opt-out. - Persons who are at least 18 years old and residing in Japan at the time of obtaining consent. - Persons with a HeartLogic index who are ready for remote monitoring by LATITUDE NXT.
	Exclusion Criteria	- Investigators who refuse to participate in this study by viewing information about this study on each collaborating institution's website or posters as an opt-out.
	Age Minimum	18age old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		heart failure
Health Condition(s) Keyword		Cardiac Failure
Health Condition(s) Code		D006333
Primary Outcome(s)		To evaluate the rate of rehospitalization for heart failure, the rate and incidence of heart failure events, death from cardiac causes, and death from all causes before and after HeartLogic activation
Secondary Outcome(s)		1. Correlate the rate of change or absolute value of HeartLogic index values with heart failure events and life expectancy. 2. Sensitivity and specificity of HeartLogic for heart failure hospitalizations analyzed by ROC analysis 3. Correlation of Heart Failure events and life expectancy by whether or not HeartLogic alert notifications are responded to after facility recognition 4. Number of alerts, follow-up period, etc. by total subjects, ICD, and CRT-D

Primary Sponsor	Boston Scientific Corporation

Name of Certified Review Board	Osaka University Clinical Research Review Committee
Address	2-2 Yamadaoka, Suita, Osaka, Japan, Osaka
Telephone	+81-6-6210-8270
E-Mail	handai-nintei@hp-crc.med.osaka-u.ac.jp
Date of approval	April. 11, 2025

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Oct. 03, 2025	(this page)	Changes
1	April. 28, 2025	Detail

List of change history