UMIN-CTR Clinical Trial

Basic information
Public title	Prognostic markers for heart failure in patients undergoing peritoneal dialysis
Acronym	Prognostic markers for HF in patients undergoing PD
Scientific Title	Prognostic markers for heart failure in patients undergoing peritoneal dialysis
Scientific Title:Acronym	Prognostic markers for HF in patients undergoing PD
Region	Japan

Condition
Condition	Chronic renal failure
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the utility of BNP and NT-proBNP as predictive markers of heart failure and identify new markers in PD patients.
Basic objectives2	Others
Basic objectives -Others	To ensure early diagnosis and intervention of heart failure, confirmation of the utility of the markers and new predictive markers of heart failure.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To confirm the utility of BNP and NT-proBNP as predictive markers of heart failure and identify new markers in PD patients.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	regularly followed-up patients
Key exclusion criteria	inpatients
Target sample size	29

Research contact person
Name of lead principal investigator	1st name Yukinao Middle name Last name Sakai
Organization	Nippon Medical School
Division name	Department of Nephrology
Zip code	113-8603
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	y-sakai@nms.ac.jp

Public contact
Name of contact person	1st name Yukinao Middle name Last name Sakai
Organization	Nippon Medical School
Division name	Department of Nephrology
Zip code	113-8603
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	y-sakai@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

Funding Source
Organization	Nippon Medical School
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Nippon Medical School Foundation
Address	1-1-5 Sendagi, Bunkyo-Ku, Tokyo
Tel	03-3822-2131
Email	clinicaltrial@nms.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 27 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 09 Month 01 Day
Date of IRB	2018 Year 08 Month 31 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We measured delta Wt, CTR, BNP, NT-proBNP, BUN, Cr, TP, Alb, Na, K, Cl, Ca, P, intact parathyroid hormone, Hb, Hematocrit, serum B2 microglobulin, Ferritin and transferrin saturation. We also evaluated the New York Heart Association classification. In addition to them, as background factors, we evaluated body mass index, primary disease, PD vintage, D/P ratio, D/D ratio, left atrial dimension, left ventricular mass index and left ventricle ejection fraction.

Management information
Registered date	2019 Year 08 Month 27 Day
Last modified on	2020 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041762