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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038307
Receipt No. R000043660
Scientific Title Characteristics and prognosis study of real-world cardiac amyloidosis
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/16

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Basic information
Public title Characteristics and prognosis study of
real-world cardiac amyloidosis
Acronym CAPTURE-AMYLOID
Scientific Title Characteristics and prognosis study of
real-world cardiac amyloidosis
Scientific Title:Acronym CAPTURE-AMYLOID
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the characteristics of patients with cardiac amyloidosis
Basic objectives2 Others
Basic objectives -Others To evaluate the prognosis of patients with cardiac amyloidosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A composite of all-cause death and hospitalization for heart failure
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who were diagnosed as cardiac amyloidosis after September 1, 2019
2. Patients in whom written informed consent was obtained
Key exclusion criteria Patients in whom written informed consent was not obtained
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Kimura
Organization Kyoto University Hospital
Division name Department of Cardiovascular Medicine
Zip code 606-8507
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507 Japan
TEL 075-751-4254
Email taketaka@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Yukiko
Middle name
Last name Nakano
Organization Kyoto University Hospital
Division name Department of Cardiovascular Medicine
Zip code 606-8507
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507 Japan
TEL 075-751-4255
Homepage URL
Email yukikom@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization None
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 Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address Yoshidakonoe-cho, Sakyo-ku, Kyoto 606-8501 Japan
Tel 075-753-4680
Email ethcom@kuhp.kyoto-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
2019 Year 11 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 Enrolling by invitation
Date of protocol fixation
2019 Year 10 Month 07 Day
Date of IRB
2019 Year 10 Month 07 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2024 Year 10 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective cohort study

Management information
Registered date
2019 Year 10 Month 16 Day
Last modified on
2019 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043660

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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