Taiwan Registry of Hypertrophic Cardiomyopathy (THIC) Research Synopsis

NCT06381778 | Recruiting

• 1 other identifier: 112006-E
• Study Type: observational
• Target: 2,600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Death

  Death

  1 year

Secondary Outcomes (1)

• CV death

  1 year

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Presence of left ventricular hypertrophy

You may qualify if:

• Presence of left ventricular hypertrophy (LVH) on echo/CMRI:
• maximal interventricular septal (IVST) and/or posterior wall thickness (PWT) ≥13 mm,
• apical wall thickness ≥15 mm or a ratio of apical to basal LV wall thickness of ≥ 1.3 at end-diastole, OR
• maximal LV wall thickness ≥ 15mm of ANY OTHER PART
• Male and female adult age ≥ 20 year-old
• Patients willing to comply with and sign the informed consent

You may not qualify if:

• Patients refuse or unable to give informed consent
• Patients unlikely to comply with the protocol or unable to understand the nature and possible consequences of the program
• Co-arctation of the aorta, severe aortic stenosis, or severe LV pressure overload
• Athletic heart
• Non-compaction cardiomyopathy

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Central Study Contacts

Yen-Wen Wu, PhD

CONTACT

+886289667000; wuyw0502@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiovascular Medical Center, Far Eastern Memorial Hospital

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: February 6, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)