Registry and Prevalence of Gene Mutation in Korean Patients With Familial Hypertrophic Cardiomyopathy

Familial Hypertrophic Cardiomyopathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792960
• Other study ID #: 4-2012-0869
• Status: Completed
• Phase: N/A
• First received: February 7, 2013
• Last updated: February 17, 2014
• Start date: February 2013
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Set the Korean Familial Hypertrophic Cardiomyopathy (KFHC) registry to study the prevalence of gene mutations in Korean patients with familial hypertrophic cardiomyopathy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

1. left ventricular maximal wall thickness = 15mm on echocardiography

2. hypertrophic cardiomyopathy patients' relatives

Exclusion Criteria:

1. other cardiomyopathy or systemic disease (e.g. fabry disease, danon disease, glycogen storage disease)

2. who deny the study entrance, especially in patients' relatives

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Cardiomyopathy, Hypertrophic, Familial
• Familial Hypertrophic Cardiomyopathy
• Hypertrophy

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1) DNA analysis	1) Identify susceptible genes for familial hypertrophic cardiomyopathy in Korean	1 year	No
Secondary	2) Prognosis of familial hypertrophic cariomyopathy	2) all-cause mortality, hospitalization for heart failure progression, stroke, heart transplantation	1 year	No