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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025734
Receipt No. R000027042
Scientific Title The study for developing a strategy for long-term morbidities and non-medical issuesin patients with adult congenital heart disease
Date of disclosure of the study information 2017/01/18
Last modified on 2019/02/05

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Basic information
Public title The study for developing a strategy for long-term morbidities and non-medical issuesin patients with adult congenital heart disease
Acronym Long-term Events in Grown-up Adult congenital heart disease collaborative studY: LEGACY
Scientific Title The study for developing a strategy for long-term morbidities and non-medical issuesin patients with adult congenital heart disease
Scientific Title:Acronym Long-term Events in Grown-up Adult congenital heart disease collaborative studY: LEGACY
Region
Japan

Condition
Condition Patients with adult congenital heart disease
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Psychosomatic Internal Medicine Obsterics and gynecology Pediatrics
Cardiovascular surgery Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purposes of this study are to examine long-term mortality and morbidity in patients with adult congeital heart disease, to determine risk factors associated with these conditions, including parameters in childhood, and to provide effective intervention.
Basic objectives2 Others
Basic objectives -Others This study is retrospective and prospective designs.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes all cause mortality
change in quality of life
Key secondary outcomes cardiovascular death, non-cardiovascular death, cardiovascular morbidities,non-cardiovascular morbidities, cahnge in NYHA, change in BNP

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Men and women 16 years of age or older
2) Patients with congenital heart disease
3) Voluntary written consent by patients or their caregivers is given after sufficient information about this study
Key exclusion criteria 1) Patients who deny informed consent
2) Patients who are judged to be inappropriate for this study by the reserchers
Target sample size 1700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Tatebe
Organization Tohoku University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1, Seiryo-cho, Aoba-ku, Sendai
TEL +81-22-717-7153
Email shuntatebe@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Tatebe
Organization Tohoku University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1, Seiryo-cho, Aoba-ku, Sendai
TEL +81-22-717-7153
Homepage URL
Email shuntatebe@cardio.med.tohoku.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Agency of 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
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
2017 Year 01 Month 18 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
2016 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is retrospective and prospective designs. To examine long-term mortality/morbidity and risk factors associated with these conditions, approximately 1,700 patients with adult congenital heart disease (ACHD) are being recruited from the database of Chronic Heart Failure Analysis and Registry in the Tohoku District 2 study (CHART-2 Study), Tohoku University, and other three ACHD centers in Japan in the period of 2016-2019. The primary endpoints are all-cause mortality and change in QOL.

Management information
Registered date
2017 Year 01 Month 18 Day
Last modified on
2019 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027042

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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