Familial Hypertrophic CardiomyopathyNCT01792960
Registry and Prevalence of Gene Mutation in Korean Patients With Familial Hypertrophic Cardiomyopathy
An observational study of Familial Hypertrophic Cardiomyopathy, run by Yonsei University at 1 site in South Korea.
Trial summary
Set the Korean Familial Hypertrophic Cardiomyopathy (KFHC) registry to study the prevalence of gene mutations in Korean patients with familial hypertrophic cardiomyopathy Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Familial Hypertrophic Cardiomyopathy
- How many people
- 99 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Aug 2013
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: familial hypertrophic cardiomyopathy patients and their relatives
Who may be able to join
- left ventricular maximal wall thickness ≥ 15mm on echocardiography
- hypertrophic cardiomyopathy patients' relatives
Who cannot join
- other cardiomyopathy or systemic disease (e.g. fabry disease, danon disease, glycogen storage disease)
- who deny the study entrance, especially in patients' relatives
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
Set the Korean Familial Hypertrophic Cardiomyopathy (KFHC) registry to study the prevalence of gene mutations in Korean patients with familial hypertrophic cardiomyopathy
- Conditions
- Familial Hypertrophic Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| familial hypertrophic cardiomyopathy | familial hypertrophic cardiomyopathy patients and their relatives |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) DNA analysis
- Identify susceptible genes for familial hypertrophic cardiomyopathy in Korean
Measured: 1 year
Secondary outcomes (1)
2) Prognosis of familial hypertrophic cariomyopathy
- all-cause mortality, hospitalization for heart failure progression, stroke, heart transplantation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792960
- Sponsor's protocol ID
- 4-2012-0869
- Status last verified
- Feb 2014
- First submitted
- 7 Feb 2013
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry and Prevalence of Gene Mutation in Korean Patients With Familial Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01792960
- Acronym / sponsor ID
- 4-2012-0869
- Conditions
- Familial Hypertrophic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Set the Korean Familial Hypertrophic Cardiomyopathy (KFHC) registry to study the prevalence of gene mutations in Korean patients with familial hypertrophic cardiomyopathy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| familial hypertrophic cardiomyopathy | – | –familial hypertrophic cardiomyopathy patients and their relatives |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- familial hypertrophic cardiomyopathy patients and their relatives
Key inclusion criteria (2 listed)
- left ventricular maximal wall thickness ≥ 15mm on echocardiography
- hypertrophic cardiomyopathy patients' relatives
Key exclusion criteria (2 listed)
- other cardiomyopathy or systemic disease (e.g. fabry disease, danon disease, glycogen storage disease)
- who deny the study entrance, especially in patients' relatives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1) DNA analysis
Time frame: 1 year
1) Identify susceptible genes for familial hypertrophic cardiomyopathy in Korean
1 secondary outcome
2) Prognosis of familial hypertrophic cariomyopathy
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Hypertrophic Cardiomyopathy, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1) DNA analysis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.