Registry and Prevalence of Gene Mutation in Korean Patien... | NCT01792960

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

NCT01792960

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Feb 19, 2014Estimated

Enrollment

99Actual

Phase

Not provided

Conditions

Familial Hypertrophic Cardiomyopathy

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Feb 7, 2013

First Submission Date that Met QC Criteria

Feb 13, 2013

First Posted Date

Feb 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2014

Last Update Posted Date

Feb 19, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

99Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
familial hypertrophic cardiomyopathy		familial hypertrophic cardiomyopathy patients and their relatives

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1) DNA analysis	1) Identify susceptible genes for familial hypertrophic cardiomyopathy in Korean	1 year

Secondary Outcomes

Measure	Description	Time Frame
2) Prognosis of familial hypertrophic cariomyopathy	2) all-cause mortality, hospitalization for heart failure progression, stroke, heart transplantation	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

familial hypertrophic cardiomyopathy patients and their relatives

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine		Seoul	Seoul	120-752	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D024741	Cardiomyopathy, Hypertrophic, Familial

Ancestor Terms

ID	Term
D002312	Cardiomyopathy, Hypertrophic
D009202	Cardiomyopathies
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided