UMIN-CTR Clinical Trial

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	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 Kenichi Middle name Last name Tsujita
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Zip code	860-8556
Address	1-1-1 Honjo, Kumamoto
TEL	096-373-5175
Email	tsujita@kumamoto-u.ac.jp

Public contact
Name of contact person	1st name Seiji Middle name Last name Takashio
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Zip code	860-8556
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	Kumamoto University
Address	1-1-1 Honjo, Kumamoto
Tel	096-373-5175
Email	cvmhisho@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	熊本中央病院　 熊本医療センター　 済生会熊本病院　 熊本赤十字病院　 熊本市民病院　　 熊本地域医療センター　 熊本労災病院　 熊本総合病院 熊本機能病院　 水俣市立総合医療センター　 人吉医療センター　 公立玉名中央病院　 荒尾市民病院　 山鹿市民医療センター　 阿蘇医療センター　 天草地域医療センター　 福岡徳州会病院　 県立延岡病院　 新別府病院

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	No longer recruiting
Date of protocol fixation	2018 Year 06 Month 26 Day
Date of IRB	2021 Year 01 Month 22 Day
Anticipated trial start date	2018 Year 06 Month 26 Day
Last follow-up date	2021 Year 03 Month 31 Day
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	2021 Year 07 Month 24 Day

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