NCT01792960

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

6 months

First QC Date

February 7, 2013

Last Update Submit

February 17, 2014

Conditions

Familial Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • 1) DNA analysis

    1\) Identify susceptible genes for familial hypertrophic cardiomyopathy in Korean

    1 year

Secondary Outcomes (1)

  • 2) Prognosis of familial hypertrophic cariomyopathy

    1 year

Study Arms (1)

familial hypertrophic cardiomyopathy

familial hypertrophic cardiomyopathy patients and their relatives

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

familial hypertrophic cardiomyopathy patients and their relatives

You may qualify if:

  • left ventricular maximal wall thickness ≥ 15mm on echocardiography
  • hypertrophic cardiomyopathy patients' relatives

You may not qualify if:

  • other cardiomyopathy or systemic disease (e.g. fabry disease, danon disease, glycogen storage disease)
  • who deny the study entrance, especially in patients' relatives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, whole blood, DNA

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic, Familial

Condition Hierarchy (Ancestors)

Cardiomyopathy, HypertrophicCardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 15, 2013

Study Start

February 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

KR(1)