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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06169358
Other study ID # KYLL-202306-100-3
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date September 1, 2024

Study information

Verified date October 2023
Source Qilu Hospital of Shandong University
Contact Xinyu Zhang
Phone 18560087699
Email zhangxinyu@sdu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study was to understand the epidemiological status of Fabry in patients with hypertrophic cardiomyopathy or left ventricular hypertrophy through multi-center early identification of high-risk patients in cardiology according to high-risk profiles, supplemented by DBS (dried blood disc) screening tools, and to explore the screening and diagnosis methods of patients with Fabry disease in cardiology, so as to promote the early identification, diagnosis and treatment of Fabry in cardiology.


Recruitment information / eligibility

Status Recruiting
Enrollment 627
Est. completion date September 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Meet diagnostic criteria for hypertrophic cardiomyopathy (HCM) in adults (age = 18 years):Imaging of one or more left ventricular segments reveals a maximum end-diastolic ventricular wall thickness of =15 mm or end-diastolic ventricular septal thickness or posterior left ventricular wall thickness of =13 mm on either cardiac imaging at rest. Exclusion Criteria: - 1. Identification of hypertrophic cardiomyopathy caused by mutations in pathogenic genes; 2. Identify the cause of left ventricular hypertrophy (LVH); 3. Aortic valve or mitral valve lesions that can cause hemodynamic changes.

Study Design


Locations

Country Name City State
China Qilu Hospital of Shandong University Jinan Jinan

Sponsors (1)

Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary diagnosis of Fabry disease Clinicians can identify high-risk patients in cardiology at an early stage according to the high-risk profile developed in this study, supplemented by the DBS (dried blood disc) screening tool, and diagnose and treat Fabry disease as early as possible through the established screening pathway for high-risk patients with Fabry disease in cardiology. 1 year
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