A Registry Study on Primary/idiopathic Triglyceride Deposit Cardiomyovasculopathy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05345223

Enrollment

193

Registered

2022-04-25

Start date

2022-03-31

Completion date

2023-12-31

Last updated

2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triglyceride Deposit Cardiomyovasculopathy

Keywords

triglyceride deposit cardiomyovasculopathy, TGCV

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	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.

Countries

Japan

Outcome results