臨床研究等提出・公開システム

Date of registration	Jan. 15, 2021
Last modified on	Mar. 17, 2022
Trial ID	jRCT1050200108

Scientific Title	The health services research of heart failure: an analysis using JROAD-DPC (J-HF study)
Public Title	J-HF study (J-HF study)

Contact for Scientific Queries	Name	Iwanaga Yoshitaka
	Affiliation	National Cerebral and Cardiovascular Center
	Address	6-1 Kishibeshim-machi Suita, Osaka #564-8565 JAPAN
	Telephone	+81-6-6170-1070
	E-mail	yiwanaga@ncvc.go.jp
Contact for Public Queries	Name	Nakao M Yoko
	Affiliation	National Cerebral and Cardiovascular Center
	Address	6-1 Kishibeshim-machi Suita, Osaka #564-8565 JAPAN
	Telephone	+81-6-6170-1070
	E-mail	nakaoym@ncvc.go.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Jan. 15, 2021
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	In the JROAD-DPC(Japanese Registry of All Cardiac and Vascular Diseases - Diagnosis Procedure Combination) between April 1, 2012 and March 31, 2021: 1) Patients aged 18 or over; 2) patients with history of hospitalization for heart failure during the observational period.
	Exclusion Criteria	None
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Heart failure
Health Condition(s) Keyword		Heart failure
Primary Outcome(s)		Re-hospitalization due to heart failure
Secondary Outcome(s)		1) Composite of cardiovascular outcomes (myocardial infarction, stroke, heart failure requiring hospitalization); 2) myocardial infarction; 3) stroke; 4) cardiovascular death; 5) all -cause death.

Primary Sponsor	Kinya Otsu

Source of Monetary Support / Secondary Sponsor	Investigator Initiative Research
Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Research Ethics Committee, National Cerebral and Cardiovascular Center
Address	6-1 Kishibeshim-machi, Suita, Osaka
Telephone	+81-6-6170-1070
E-Mail	rec-office-ac@ncvc.go.jp
Approval Status	Approval
Date of approval	June. 12, 2020

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Mar. 17, 2022	(this page)	Changes
1	Jan. 15, 2021	Detail

List of change history