UMIN-CTR Clinical Trial

Basic information
Public title	The research about the significance of urinary titin in cardiomyopathy
Acronym	Urinary titin in cardiomyopathy
Scientific Title	The research about the significance of urinary titin in cardiomyopathy
Scientific Title:Acronym	Urinary titin in cardiomyopathy
Region	Japan

Condition
Condition	cardiomyopathy
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the concentration of urinary titin of the patients with cardiomyopathy and the normal control.
Basic objectives2	Others
Basic objectives -Others	The purpose of this study is to investigate in a cross-sectional way the correlation between the concentration of urinary titin in the patients with cardiomyopathy and normal control and the basic characteristics of participants, such as the types of cardiomyopathy, severity, and laboratory findings. This study is a preliminary research to acquire the data of urinary titin and design appropriately the future research for the feasibility to detect the cardiomyopathy using urinary titin, and is to be performed exploratorily.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The concentration of urinary titin
Key secondary outcomes	Diagnosis, sex, age, height, weight, family history, past illness, classification of NYHA, symptom, blood pressure, pulse rate, WBC, RBC, Hb, Plt, TP, Alb, AST, ALT, CK, Na, K, Cl, BUN, Cr, eGFR, BNP, urinary protein, urinary glucose, urinary RBC, %EF, IVST, PWT

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) The inpatients and outpatients of the department of cardiovascular medicine in Kobe university hospital, who have cardiomyopathy, such as dilated cardiomyopathy, hypertrophic cardiomyopathy, ischemic cardiomyopathy, congenital heart disease, and normal control. (2) The participants with written consent.
Key exclusion criteria	The patients with myodegeneration diseases such as muscular dystrophy. The patients after vigorous exercise or intramuscular injection such that the serum creatine kinase would be elevated . The person who had a proposal of the cancellation about using samples for this study.
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Seimi Middle name Last name Kobayashi
Organization	Kobe university hospital
Division name	The department of cardiovascular medicine
Zip code	6500017
Address	7-5-2, Kusunoki-cho, Cyuo-ku, Kobe city, Hyogo
TEL	0783825846
Email	seimik@med.kobe-u.ac.jp

Public contact
1st name of contact person	1st name Matsumoto Middle name Last name Kensuke
Organization	Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name	Division of cardiovascular medicine
Zip code	6500017
Address	7-5-2, Kusunoki-cho, Cyuo-ku, Kobe city, Hyogo
TEL	0783825846
Homepage URL
Email	kenmatsu@med.kobe-u.ac.jp

Sponsor
Institute	Kobe university
Institute
Department

Funding Source
Organization	Kobe university
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)	Japan Agency for Medical Research and Deveopement

IRB Contact (For public release)
Organization	Division of cardiovascular medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Address	7-5-2, Kusunoki-cho, Cyuo-ku, Kobe city, Hyogo
Tel	0783825846
Email	seimik@med.kobe-u.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	神戸大学医学部付属病院

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 22 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	61
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	2017 Year 03 Month 07 Day
Date of IRB	2017 Year 02 Month 20 Day
Anticipated trial start date	2017 Year 03 Month 22 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Design: preliminary exploratory research Participants: the inpatients and outpatients of the department of cardiovascular medicine in Kobe university hospital from March 2017 to March 2018, with written consent and be coincident with a selection standard, and normal control(healthy volunteer), who are recruited by the poster. Measurement items: diagnosis, sex, age, height, weight, family history, past illness, classification of NYHA, symptom, blood pressure, pulse rate, WBC, RBC, Hb, Plt, TP, Alb, AST, ALT, CK, Na, K, Cl, BUN, Cr, eGFR, BNP, urinary protein, urinary glucose, urinary RBC, %EF, IVST, PWT.

Management information
Registered date	2017 Year 03 Month 22 Day
Last modified on	2019 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030593