臨床研究等提出・公開システム

Scientific Title	Development of a Scoring System for the Diagnostic Evaluation of Asian Patients with Heart Failure with Preserved Ejection Fraction
Public Title	Development of a Scoring System for the Diagnostic Evaluation of Asian Patients with HFpEF

Contact for Scientific Queries	Name	Obokata Masaru
	Affiliation	Gunma University Hospital
	Address	3-39-15 Showa-machi, Maebashi, Gunma
	Telephone	+81-272208145
	E-mail	obokata.masaru@gunma-u.ac.jp
Contact for Public Queries	Name	Obokata Masaru
	Affiliation	Gunma University Hospital
	Address	3-39-15 Showa-machi, Maebashi, Gunma
	Telephone	+81-272208145
	E-mail	obokata.masaru@gunma-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 21, 2023
Actual date of first enrollment
Target sample size		750
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who underwent exercise stress echocardiography for the evaluation of symptoms of heart failure such as dyspnea Patients over 18 years of age Patients with a left ventricular ejection fraction of 50% or greater
	Exclusion Criteria	Patients with a history of hospitalization for heart failure Significant left heart valvular disease Cardiomyopathies Pulmonary hypertension or exercise induced pulmonary hypertension other than group 2 Pericarditis, myocarditis, epicarditis Patients with a previous left ventricular ejection fraction <40% Patients who are judged to be unsuitable as research subjects by the principal investigator or co-investigators
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		heart failure with preserved ejection fraction
Intervention(s)		None
Health Condition(s) Keyword		heart failure
Intervention(s) Keyword		none
Health Condition(s) Code
Intervention(s) Code		None
Primary Outcome(s)		Presence of HFpEF
Secondary Outcome(s)

Primary Sponsor	Gunma University Hospital

Source of Monetary Support / Secondary Sponsor	Nippon Boehringer Ingelheim Co., Ltd.
Secondary Sponsor	Not applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Gunma University Hospital, Clinical Research Review Board
Address	3-39-15 Showa-machi, Maebashi, Gunma, Gunma
Telephone	+81-27-220-8740
E-Mail	irb-jimukk-ciru@ml.gunma-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 20, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history