A Registry Study on Primary/idiopathic Triglyceride Deposit Cardiomyovasculopathy
1 other identifier
observational
193
1 country
7
Brief Summary
The objective of this study is to construct a registry; in order to understand the onset status of triglyceride deposit cardiomyovasculopathy (TGCV) in Japan with patients' background and natural history of the disease, and to explore disease-specific prognostic factors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2022
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2022
CompletedStudy Start
First participant enrolled
March 31, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedDecember 20, 2024
December 1, 2024
1.8 years
March 29, 2022
December 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The period between the date of TGCV diagnosis and the date of death due to any cause
The period is from the date of diagnosis of TGCV to the date of death due to any cause. Survival and lost follow-up cases will be censored on the final confirmation date of survival.
10 years
Secondary Outcomes (4)
Comparison of subjective symptoms, laboratory findings, and event occurrence before and after tricaprin therapy: Washout rate of BMIPP (%)
10 years
Comparison of subjective symptoms, laboratory findings, and event occurrence before and after tricaprin therapy: LVEF (%) (UCG or QGS)
10 years
Comparison of subjective symptoms, laboratory findings, and event occurrence before and after tricaprin therapy: Any cardiovascular events
10 years
Presence (date of occurrence or treatment) or absence of various events
10 years
Study Arms (1)
TGCV
Patients who have been confirmed as TGCV by a cardiologist.
Eligibility Criteria
Adult patients (excluding under 20 years old) who have been confirmed as TGCV based on the diagnostic criteria for TGCV by a cardiologist.
You may qualify if:
- Adult patients who have been confirmed as TGCV based on the diagnostic criteria for TGCV
You may not qualify if:
- The patients who refused to participate in the study by opt-out
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Aichi Medical University
Nagakute, Aichi-ken, 4801195, Japan
Nagoya University
Nagoya, Aichi-ken, 4668560, Japan
Chiba University Graduate School of Medicine
Chiba, Chiba, 2608677, Japan
Kyushu University
Fukuoka, Fukuoka, 8128582, Japan
Hyogo Medical University
Nishinomiya, Hyōgo, 6638501, Japan
Osaka University Hospital
Suita, Osaka, 5650871, Japan
Juntendo University
Bunkyo, Tokyo, 1138431, Japan
Study Officials
- PRINCIPAL INVESTIGATOR
Ken-ichi Hirano, MD, PhD
Department of Triglyceride Science, Graduate School of Medicine, Osaka University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2022
First Posted
April 25, 2022
Study Start
March 31, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
December 20, 2024
Record last verified: 2024-12