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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01792960
First received: February 7, 2013
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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


Condition
Familial Hypertrophic Cardiomyopathy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 1) DNA analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    1) Identify susceptible genes for familial hypertrophic cardiomyopathy in Korean


Secondary Outcome Measures:
  • 2) Prognosis of familial hypertrophic cariomyopathy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    2) all-cause mortality, hospitalization for heart failure progression, stroke, heart transplantation


Biospecimen Retention:   Samples With DNA

serum, whole blood, DNA


Enrollment: 99
Study Start Date: February 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
familial hypertrophic cardiomyopathy
familial hypertrophic cardiomyopathy patients and their relatives

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

familial hypertrophic cardiomyopathy patients and their relatives

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792960

Locations
Korea, Republic of
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01792960     History of Changes
Other Study ID Numbers: 4-2012-0869
Study First Received: February 7, 2013
Last Updated: February 17, 2014
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Cardiomyopathy, Hypertrophic, Familial
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 18, 2014