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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032799
Receipt No. R000037379
Scientific Title Multicenter prospective observational study to examine the predictability of pathological assessment for staging of cardiomyopathy
Date of disclosure of the study information 2018/06/01
Last modified on 2020/06/01

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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 No longer recruiting
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
Date trial data considered complete
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
2020 Year 06 Month 01 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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