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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033471
Receipt No. R000038167
Scientific Title Kumamoto cardiac amyloidosis survey
Date of disclosure of the study information 2018/09/01
Last modified on 2018/07/22

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Basic information
Public title Kumamoto cardiac amyloidosis survey
Acronym Kumamoto cardiac amyloidosis survey
Scientific Title Kumamoto cardiac amyloidosis survey
Scientific Title:Acronym Kumamoto cardiac amyloidosis survey
Region
Japan

Condition
Condition Cardiac amyloidosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate patients characteristics, clinical course including the process of the diagnosis, treatment strategy, and prognostic factors in patients with cardiac amyloidosis.
Basic objectives2 Others
Basic objectives -Others Prospective epidemiological survey of cardiac amyloidosis in Japan
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)All cause death
Key secondary outcomes 1) Cardiovascular death and non cardiovascular death
2) Unplanned hospitalization due to worsening heart failure
3) Exacerbation of symptom
4) Change of treatment strategy
5) Change of laboratory and echocardiographic data

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 Cardiac amyloidosis patients with
1)AL amyloidosis
2)Mutant ATTR amyloidosis
3)Wild type ATTR amyloidosis
Key exclusion criteria A pregnant woman or pregnant patients
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Tsujita
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto
TEL 096-373-5175
Email tsujita@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiji Takashio
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto
TEL 096-373-5175
Homepage URL
Email s-takash@kumamoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine,
Graduate School of Medical Sciences, Kumamoto University
Institute
Department

Funding Source
Organization Department of Cardiovascular Medicine,
Graduate School of Medical Sciences, Kumamoto University
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
Address
Tel
Email

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
2018 Year 09 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 Open public recruiting
Date of protocol fixation
2018 Year 06 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We investigate the patient status and clinical event every year for five years.

Management information
Registered date
2018 Year 07 Month 22 Day
Last modified on
2018 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038167

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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