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NCT06381778 Clinical Trial

Taiwan Registry of Hypertrophic Cardiomyopathy (THIC) Research Synopsis

Hypertrophic Cardiomyopathy Clinical Trial

Official title:
Taiwan Registry of Hypertrophic Cardiomyopathy (THIC) Research Synopsis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06381778
Other study ID # 112006-E
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 6, 2023
Est. completion date December 1, 2027

Study information
Verified date April 2024
Source Far Eastern Memorial Hospital
Contact Yen-Wen Wu, PhD
Phone +886289667000
Email wuyw0502@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hypertrophic cardiomyopathy (HCM) is hallmarked by the presence of left ventricular hypertrophy (LVH) and may present various symptoms including arrhythmia and heart failure. Mutations in the genes related to sarcomeric proteins and metabolic disorders are known causes of HCM. However, it remains required to further explore the prevalence of HCM in the context of Taiwanese' genetic background. Additionally, certain rare diseases that affect the heart, including Fabry disease, cardiac amyloidosis, may present LVH, which makes precise diagnosis among HCM and these diseases more challenging. In this TSOC multi-center registry, we aim to systematically evaluate the clinical, genetic, biochemical features,prevalence, and possible natural course of HCM and relevant rare diseases such as Fabry disease in Taiwan. In the meanwhile, we may also generate the specific "red-flag" signs of Fabry disease in Taiwan.

Recruitment information / eligibility
Status Recruiting
Enrollment 2600
Est. completion date December 1, 2027
Est. primary completion date December 1, 2027
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 1. Presence of left ventricular hypertrophy (LVH) on echo/CMRI: 2. maximal interventricular septal (IVST) and/or posterior wall thickness (PWT) =13 mm, 3. apical wall thickness =15 mm or a ratio of apical to basal LV wall thickness of = 1.3 at end-diastole, OR 4. maximal LV wall thickness = 15mm of ANY OTHER PART 5. Male and female adult age = 20 year-old 6. Patients willing to comply with and sign the informed consent Exclusion Criteria: 1. Patients refuse or unable to give informed consent 2. Patients unlikely to comply with the protocol or unable to understand the nature and possible consequences of the program 3. Co-arctation of the aorta, severe aortic stenosis, or severe LV pressure overload 4. Athletic heart 5. Non-compaction cardiomyopathy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Far Eastern Memorial Hospital New Taipei City

Sponsors (1)
Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Death Death 1 year
Secondary CV death CV death 1 year
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