臨床研究等提出・公開システム

Date of registration	Sept. 07, 2020
Last modified on	Oct. 12, 2023
Trial ID	jRCT1052200052

Scientific Title	Japanese HIS-bundle pacing for patient with indication of Cardiac Resynchronization Therapy Trial
Public Title	J-HIS-CRT

Completion date	Aug. 17, 2024
Result actual enrolment	7
Baseline Characteristics	Seven patients were enrolled in the study and one withdrew consent. Age was 67.7 +-16.3 (mean +-standard deviation) in the CRT group and 66.3 +-8.8 in the His group, and the proportion of women was 33.3% in the CRT group and 0.0% in the His group, with no significant differences between the two groups.
Participant flow	The enrolment period was 2.5 years until 31 March 2023, but the study was discontinued due to poor progress.
Adverse events	Adverse events No adverse events occurred.
Outcome measures	No analysis was conducted due to the discontinuation of the study.
Brief summary	No analysis was conducted due to the discontinuation of the study.
Date of posting of results summaries	Aug. 31, 2023

Plan to share IPD	No
Plan description	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1052200052

Contact for Scientific Queries	Name	Kusano Kengo
	Affiliation	National Cerebral and Cardiovascular Center Hospital
	Address	6-1 Kishibe Shimmachi, Suita, Osaka, Japan
	Telephone	+81-6-6170-1070
	E-mail	kusanokengo@ncvc.go.jp
Contact for Public Queries	Name	Yurugi Maki
	Affiliation	National Cerebral and Cardiovascular Center Hospital
	Address	6-1 Kishibe Shimmachi, Suita, Osaka, Japan
	Telephone	+81-6-6170-1070
	E-mail	yurugi.maki@ncvc.go.jp

Recruitment status	Complete

Anticipated date of first enrollment		Sept. 07, 2020
Actual date of first enrollment		Mar. 05, 2021
Target sample size		50
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Subject is 20 years of age or older at the time of consent acquisition 2. Subject who meets CRT indications according to the guidelines of the Japanese Circulation Society 3. Subject planning to implant CRT 4. Subject has signed and dated the informed consent form
	Exclusion Criteria	1. Subject with a history of CRT implantation 2. Subject with severe heart failure that requires continuous administration of cardiotonic 3. Subject with unstable angina, acute myocardial infarction within 40 days, or within 3 months after coronary artery invasive treatment 4. Subject scheduled for tricuspid valve surgery 5. Pregnant woman 6. Subject participating in other clinical trials or intervention trials 7. Subject judged to be inappropriate to this study for other reasons by the investigator
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Heart Failure
Intervention(s)		His-bundle pacing
Health Condition(s) Keyword		Heart Failure
Primary Outcome(s)		Responder rate 6 months after implantation
Secondary Outcome(s)		1. Amount of change in cardiac function by myocardial scintigraphy at 6 months after implantation (left ventricular ejection fraction: LVEF, left ventricular end systolic volume: LVESV, etc.) 2. Prognosis at 6 and 24 months after implantation (survival rate and cardiovascular event non-incidence rate) 3. Amount of change in NYHA at 6 and 24 months after implantation 4. Amount of change in serum natriuretic peptide levels at 6 and 24 months after implantation

Secondary Sponsor

Source of Monetary Support	Intramural Research Fund (30-3-1)for Cardiovascular Diseases of National Cerebral and Cardiovascular Center Prospective Intervention Study Using the Existing Devices to Develop a New Therapeutic Guideline
Secondary Sponsor	Not applicable

Name of Certified Review Board	Osaka Metropolitan University Hospital Certified Review Board
Address	6th floor of Abeno Medix,1-2-7 Asahicho,Abeno-ku,Osaka, Osaka
Telephone	+81-6-6645-3456
E-Mail	irb@med.osaka-cu.ac.jp
Approval Status	Approval
Date of approval	Aug. 21, 2020

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
10	Oct. 12, 2023	(this page)	Changes
9	April. 11, 2023	Detail	Changes
8	Dec. 14, 2022	Detail	Changes
7	Sept. 23, 2022	Detail	Changes
6	Dec. 09, 2021	Detail	Changes
5	Aug. 30, 2021	Detail	Changes
4	Mar. 10, 2021	Detail	Changes
3	Feb. 12, 2021	Detail	Changes
2	Jan. 29, 2021	Detail	Changes
1	Sept. 07, 2020	Detail

List of change history