A Registry Study on Primary/Idiopathic Triglyceride Deposit Cardiomyovasculopathy

November 21, 2023 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Chiba, Japan, 2608677
        • Recruiting
        • Chiba University Hospital
    • Aichi
      • Nagakute, Aichi, Japan, 4801195
        • Recruiting
        • Aichi Medical University
    • Osaka
      • Suita, Osaka, Japan, 5650871
        • Recruiting
        • Osaka University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (excluding under 20 years old) who have been confirmed as TGCV based on the diagnostic criteria for TGCV by a cardiologist.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
TGCV
Patients who have been confirmed as TGCV by a cardiologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of subjective symptoms, laboratory findings, and event occurrence before and after tricaprin therapy: Washout rate of BMIPP (%)
Time Frame: 10 years
10 years
Comparison of subjective symptoms, laboratory findings, and event occurrence before and after tricaprin therapy: LVEF (%) (UCG or QGS)
Time Frame: 10 years
10 years
Comparison of subjective symptoms, laboratory findings, and event occurrence before and after tricaprin therapy: Any cardiovascular events
Time Frame: 10 years
10 years
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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Osaka University Graduate School of Medicine

Investigators

  • Principal Investigator: Ken-ichi Hirano, MD, PhD, Department of Triglyceride Science, Graduate School of Medicine, Osaka University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20334(T2)-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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