臨床研究等提出・公開システム

Date of registration	Feb. 22, 2024
Last modified on	Feb. 22, 2024
Trial ID	jRCT1040230157

Scientific Title	Quantitative assessment of physical activity in heart failure patients and association between physical activity and exacerbation of heart failure
Public Title	Quantitative assessment of physical activity in heart failure patients and association between physical activity and exacerbation of heart failure

Contact for Scientific Queries	Name	Kakita Saori
	Affiliation	Gifu University
	Address	1-1 Yanagido, Gifu City, Gifu Prefecture
	Telephone	+81-582933253
	E-mail	kakita.saori.j0@f.gifu-u.ac.jp
Contact for Public Queries	Name	Kakita Saori
	Affiliation	Gifu University
	Address	1-1 Yanagido, Gifu City, Gifu Prefecture
	Telephone	+81-58-293-3253
	E-mail	kakita.saori.j0@f.gifu-u.ac.jp

Recruitment status	Pending


Anticipated date of first enrollment		Feb. 22, 2024
Target sample size		150
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Inpatients Patients 20 years of age or older admitted for the first time due to heart failure or re-hospitalized due to acute worsening of heart failure Patients with EF less than 50% at the time of admission Patients receiving medical treatment Patients who require heart failure management even after discharge from the hospital Patients whose written consent for participation in this study is obtained.
	Exclusion Criteria	Patients with New York Heart Association Classification (NYHA Classification) IV Patients who are not discharged to home Patients with dementia, psychiatric disease, or orthopedic disease Patients who are judged by their physicians to be inappropriate for inclusion in the study Patients who cannot give consent to participate in this study.
	Age Minimum	20age old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		heart failure
Health Condition(s) Code		D046650
Primary Outcome(s)		Emergence of new heart failure symptoms (an exacerbation is defined as one of the following symptoms) Edema and shortness of breath: lasting 3 days Weight gain: 2-3 kg/week
Secondary Outcome(s)		readmission to a hospital

Primary Sponsor	Gifu University

Source of Monetary Support	JAPAN SOCIETY FOR PROMOTION OF SCIENCE

Name of Certified Review Board	Gifu University Graduate School of Medicine Medical Research Ethics Committee
Address	1-1 Yanagido, Gifu City, Gifu Prefecture, Gifu
Telephone	+81-58-293-3253
E-Mail	kakita.saori.j0@f.gifu-u.ac.jp

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none