UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025734 |
|---|---|
| Receipt number | 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 14:31:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Obstetrics 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
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
shuntatebe@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027042
