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Completed

NCT Number: NCT05345223

A Registry Study on Primary/idiopathic Triglyceride Deposit Cardiomyovasculopathy

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.

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Key information

Conditions

Triglyceride Deposit Cardiomyovasculopathy

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aichi Medical University, Nagakute, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The period between the date of TGCV diagnosis and the date of death due to any cause

    Time frame: 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 outcomes

  1. Comparison of subjective symptoms, laboratory findings, and event occurrence before and after tricaprin therapy: Washout rate of BMIPP (%)

    Time frame: 10 years

  2. Comparison of subjective symptoms, laboratory findings, and event occurrence before and after tricaprin therapy: LVEF (%) (UCG or QGS)

    Time frame: 10 years

  3. Comparison of subjective symptoms, laboratory findings, and event occurrence before and after tricaprin therapy: Any cardiovascular events

    Time frame: 10 years

  4. Presence (date of occurrence or treatment) or absence of various events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Osaka University Graduate School of Medicine

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2022
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.