A Registry Study on Primary/idiopathic Triglyceride Deposit Cardiomyovasculopathy

Completed

• Conditions: Triglyceride Deposit Cardiomyovasculopathy

• Registration Number: NCT05345223
• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-29
• Study Start: 2022-03-31
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-25
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

• Adult patients who have been confirmed as TGCV based on the diagnostic criteria for TGCV

Exclusion Criteria

• The patients who refused to participate in the study by opt-out

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The period between the date of TGCV diagnosis and the date of death due to any cause	10 years	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of subjective symptoms, laboratory findings, and event occurrence before and after tricaprin therapy: Any cardiovascular events	10 years
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
Presence (date of occurrence or treatment) or absence of various events	10 years	To measure the period from the date of diagnosis of TGCV to the date the following event occurs: non-fatal myocardial infarction by the outcome assessment, non-fatal stroke, hospitalization for heart failure, CABG, PCI, TVR, pacemaker/ICD implantation, CRT, VAD, acute coronary syndrome requiring hospitalization, hospitalization/device activation/heart transplantation due to fatal arrhythmia. However, surgery scheduled at the time of diagnosis will not be treated as an event.

Trial Locations

Locations (7)

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan

Nagoya University; 🇯🇵 Nagoya, Aichi, Japan

Hyogo Medical University; 🇯🇵 Nishinomiya, Hyogo, Japan

Juntendo University; 🇯🇵 Bunkyo, Tokyo, Japan

Chiba University Graduate School of Medicine; 🇯🇵 Chiba, Japan

Kyushu University; 🇯🇵 Fukuoka, Japan

Aichi Medical University; 🇯🇵 Nagakute, Aichi, Japan