UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study for developing a strategy for long-term morbidities and non-medical issuesin patients with adult congenital heart disease
Title of the study (Brief title)	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	Shunsuke Tatebe
Organization	Tohoku University Hospital
Division name	Department of Cardiovascular Medicine
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	Shunsuke Tatebe
Organization	Tohoku University Hospital
Division name	Department of Cardiovascular Medicine
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 09 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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