臨床研究等提出・公開システム

Japanese

Date of registration	May. 19, 2025
Last modified on	May. 19, 2025
Trial ID	jRCT1031250108

Scientific Title	Effects of sacubitril-valsartan on cardiac function and body fluid volume in peritoneal dialysis patients
Public Title	PD&ARNI

Contact for Scientific Queries	Name	Osano Keiichi
	Affiliation	University of Yamanashi Hospital
	Address	1110 Shimokawahigashi, Chuo City, Yamanashi Prefecture
	Telephone	+81-552732288
	E-mail	kosano@yamanashi.ac.jp
Contact for Public Queries	Name	Osano Keiichi
	Affiliation	University of Yamanashi Hospital
	Address	1110 Shimokawahigashi, Chuo City, Yamanashi Prefecture
	Telephone	+81-552732288
	E-mail	kosano@yamanashi.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 19, 2025
Actual date of first enrollment
Target sample size		20
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who meet all of the following criteria will be included. 1. Adult patients, regardless of gender, who visit the Department of Nephrology at Yamanashi University Hospital and have been undergoing peritoneal dialysis for at least six months. 2. Peritoneal dialysis patients with hypertension. 3. Patients who can provide written informed consent to participate in this study. Consent must be given by the individual.
	Exclusion Criteria	1.Patients who meet the contraindications for sacubitril valsartan 2.Patients who were taking sacubitril valsartan before enrollment in the study 3.If a doctor determines that the person is unsuitable for the program
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Chronic kidney disease G5D Peritoneal dialysis patient with hypertension
Intervention(s)		Oral administration of sacubitril valsartan
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Changes in LVEF 3 and 6 months after taking Sacubitril Valsartan compared to before administration
Secondary Outcome(s)

Primary Sponsor	Novartis

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Yamanashi University Faculty of Medicine Ethics Committee
Address	1110 Shimokawahigashi, Chuo City, Yamanashi Prefecture, Yamanashi
Telephone	+81-55-273-1111
E-Mail	rec-med@yamanashi.ac.jp
Approval Status	Approval
Date of approval	May. 15, 2025

Plan to share IPD	Yes
Plan description	In order to make it impossible to identify at a glance who the information belongs to, information that can identify an individual will be deleted from the information handled in this research and a unique code will be attached to it. The corresponding table of personal information and codes will be stored on the hard disks of separate computers in the department to which the principal investigator belongs, separated from the outside world. The researcher who handles the information should password manage the computer that handles the research information, and store the information after careful handling to prevent loss or leakage of the information.

Plan to share IPD

Yes

Plan description

In order to make it impossible to identify at a glance who the information belongs to, information that can identify an individual will be deleted from the information handled in this research and a unique code will be attached to it. The corresponding table of personal information and codes will be stored on the hard disks of separate computers in the department to which the principal investigator belongs, separated from the outside world. The researcher who handles the information should password manage the computer that handles the research information, and store the information after careful handling to prevent loss or leakage of the information.

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none