UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058135 |
|---|---|
| Receipt number | R000066402 |
| Scientific Title | Impact of LDL-C Trajectories and Cumulative Burden on Coronary Artery Disease Risk in Familial Hypercholesterolemia: The J-FH BURDEN Study, 2010-2022 |
| Date of disclosure of the study information | 2025/06/10 |
| Last modified on | 2025/06/06 21:00:52 |
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Basic information
Public title
Impact of LDL-C Trajectories and Cumulative Burden on Coronary Artery Disease Risk in Familial Hypercholesterolemia
Acronym
The J-FH BURDEN Study, 2010-2022
Scientific Title
Impact of LDL-C Trajectories and Cumulative Burden on Coronary Artery Disease Risk in Familial Hypercholesterolemia: The J-FH BURDEN Study, 2010-2022
Scientific Title:Acronym
The J-FH BURDEN Study, 2010-2022
Region
| Japan |
Condition
Condition
Familial Hypercholesterolemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate and quantify the coronary heart disease (CHD) risk associated with long-term trajectories and cumulative exposure of low-density lipoprotein cholesterol (LDL-C) among individuals whose LDL-C levels meet the diagnostic thresholds for heterozygous (HeFH; >=250 mg/dL) or homozygous (HoFH; >=370 mg/dL) familial hypercholesterolemia.
Basic objectives2
Others
Basic objectives -Others
analysis of subgroup differences and treatment-effect modification
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
First Coronary Heart Disease
Key secondary outcomes
Revascularisation
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals with record linkage between medical claims data (including diagnoses such as hypertension, diabetes, and dyslipidemia, as well as prescriptions and procedures) and specific health checkup data, in whom at least one LDL-C measurement is available in the health checkup records between April 1, 2010, and March 31, 2022.
LDL-C levels >=250 mg/dL (HeFH threshold) or >=370 mg/dL (HoFH threshold) recorded at least once during the study period
Age between 40 and 75 years at the time of the first qualifying LDL-C record
Key exclusion criteria
Individuals with a documented history of coronary heart disease (CHD) at baseline or at the start of follow-up (excluded from the main cohort but retained in restricted cubic spline and sensitivity analyses).
Individuals with implausible or erroneous LDL-C measurements (e.g., >=999 mg/dL).
Target sample size
200000
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Goto |
Organization
Juntendo university
Division name
Department of Clinical Genetics
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
khirano@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Goto |
Organization
Juntendo University
Division name
Clinical genetics
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
khirano@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Juntendo University Ethics Committee for Medical Research
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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
| 2025 | Year | 06 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective database research
Management information
Registered date
| 2025 | Year | 06 | Month | 10 | Day |
Last modified on
| 2025 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066402
