UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter prospective observational study to examine the predictability of pathological assessment for staging of cardiomyopathy
Acronym	Multicenter prospective observational study with pathological assessment in cardiomyopathy
Scientific Title	Multicenter prospective observational study to examine the predictability of pathological assessment for staging of cardiomyopathy
Scientific Title:Acronym	Multicenter prospective observational study with pathological assessment in cardiomyopathy
Region	Japan

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

Objectives
Narrative objectives1	To examine a pathological assessment with electron microscopy for predicting cardiac prognosis, including reverse remodeling, in multicenter prospective observational study and to investigate for the establishment of blood markers related to cardiac prognosis and pathological changes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cardiac event (cardiac death or LVAD implantation)
Key secondary outcomes	Reverse remodeling, change of LVEF, change of LV dimension

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. Patients (LVEF<40%) who consent to participation and have a scheduled myocardial biopsy within 1 month 2. Patients without coronary artery disease or valvular disease as a major cause of cardiac dysfunction
Key exclusion criteria	1. Patients with systemic disease with poor prognosis (within 1 year) 2. Patients with LVAD support 3. no follow-up 4. Patients without standard treatment 5. Patients judged to be inappropriate by investigator
Target sample size	180

Research contact person
Name of lead principal investigator	1st name Yasushi Middle name Last name Sakata
Organization	Osaka University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code	565-0871
Address	2-2 Yamadaoka, Suita, Osaka, 565-0871 Japan
TEL	06-6879-3631
Email	yasushisk@cardiology.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Tomohito Middle name Last name Ohtani
Organization	Osaka University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code	565-0871
Address	2-2 Yamadaoka, Suita, Osaka, 565-0871 Japan
TEL	06-6879-3638
Homepage URL
Email	ohtani@cardiology.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committee
Address	Yamadaoka 2-15, Suita City, Osaka
Tel	06-6210-8296
Email	rinri@hp-crc.med.osaka-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	大阪大学医学部附属病院（大阪府）、国立循環器病研究センター(大阪府)、東京大学医学部附属病院（東京都）、名古屋大学医学部附属病院（愛知県）、大阪急性期・総合医療センター（大阪府）

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 01 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 05 Month 27 Day
Date of IRB	2018 Year 05 Month 28 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry	2021 Year 09 Month 28 Day
Date trial data considered complete	2021 Year 10 Month 01 Day
Date analysis concluded

Other
Other related information	This study is a prospective observational study. Data for analysis is as follows: *Pathological findings (electron microscopic assessments) *Cardiac events *Echocardiographic data *Patients characteristics, including laboratory data

Management information
Registered date	2018 Year 05 Month 31 Day
Last modified on	2022 Year 06 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037379