UMIN-CTR Clinical Trial

Basic information
Public title	HE4, yamamotoM
Acronym	HE4, yamamotoM
Scientific Title	HE4, yamamotoM
Scientific Title:Acronym	HE4, yamamotoM
Region	Japan

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

Objectives
Narrative objectives1	To investigate the clinical utility of HE4 measurement in patients with DCM
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The study endpoint was a composite of all-cause death, left ventricular assist device (LVAD) implantation, and hospitalization for HF events. Furthermore, composite of all-cause death and LVAD implantation were defined as hard endpoint.
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	21 years-old <=
Age-upper limit	86 years-old >=
Gender	Male and Female
Key inclusion criteria	DCM
Key exclusion criteria	Tumor-bearing and HD
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Tsujita
Organization	Kumamoto University
Division name	Department of Cardiovascular Medicine, Faculty of Life Sciences
Zip code	8608556
Address	1-1-1, Honjyo, Chuo-ku, Kumamoto
TEL	+81963735175
Email	tsujita@kumamoto-u.ac.jp

Public contact
Name of contact person	1st name Shinsuke Middle name Last name Hanatani
Organization	Kumamoto University
Division name	Department of Cardiovascular Medicine, Faculty of Life Sciences
Zip code	8608556
Address	1-1-1, Honjyo, Chuo-ku, Kumamoto
TEL	+81963735175
Homepage URL
Email	s-hanata@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kumamoto University
Address	1-1-1, Honjyo, Chuo-ku, Kumamoto
Tel	+81963735175
Email	yamamo-m@kumamoto-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

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 20 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	87
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 01 Day
Date of IRB	2019 Year 02 Month 04 Day
Anticipated trial start date	2017 Year 04 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 serum HE4 levels of 87 patients with DCM and followed their echocardiographic parameters and cardiovascular events.

Management information
Registered date	2021 Year 01 Month 20 Day
Last modified on	2021 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049166