Cardiomyopathy, HypertrophicCHCSNCT02696135
The Chinese Hypertrophic Cardiomyopathy Study(CHCS)
An observational study of Cardiomyopathy, Hypertrophic, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Hypertrophic cardiomyopathy (HCM) is one of the most common inherited cardiac diseases, with a prevalence of ∼0.2%. Sudden cardiac death (SCD), heart failure and stroke are the major poor outcomes of HCM. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathy, Hypertrophic
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2011to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with HCM are recruited from multiple centers in China between March 23, 2016 and December 31, 2025.
Inclusion criteria: Patients with HCM diagnosed by observation of unexplained maximal left ventricle wall thickness ≥15 mm on echocardiography and/or cardiac magnetic resonance imaging or or ≥13 mm for individuals with family history of HCM.
Exclusion criteria: Individuals with other cardiac or systemic diseases capable of producing that magnitude of cardiac hypertrophy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai hospital
Beijing, Beijing Municipality, 100037
Lei Song, MD.& PhD., 86-13810532620, clinicalfw@163.com
Lei Song, MD.& PhD., 86-18600197655, lsongqd@yahoo.com
About this study
Hypertrophic cardiomyopathy (HCM) is one of the most common inherited cardiac diseases, with a prevalence of ∼0.2%. Sudden cardiac death (SCD), heart failure and stroke are the major poor outcomes of HCM. Although about half of the patients were found to be caused by mutations mainly located in genes encoding sarcomere proteins, the causes in a significant proportion of patients with HCM are still unknown. Even in the patients with sarcomere mutations, the molecular pathways that eventually lead to cardiac hypertrophy are remained to be revealed. Furthermore, HCM presents with significant heterogeneity. SCD risk stratification and prevention by ICD are necessary. However, the strategy of SCD risk stratification recommended by the 2011 ACCF/AHA and 2014 ESC guidelines were based mainly on the evidence derived from American and European countries. The accuracy of these guidelines in Chines patients with HCM was not evaluated yet.
Read the detailed description
In the present study, patients with HCM are recruited prospectively after informed consent was given. The investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hr Holter, echocardiography, MRI and other examinations if necessary. The specimens retained include blood for all patients and myocardium for patients receive surgery of myocardial myectomy. Multi-omics screening, including genomics, epigenomics, transcriptomics, proteomics, metabolomics, will be performed to identified novel disease genes, signal pathway or processes, genetic risk factors and potential therapy targets of HCM. Furthermore, besides examining the accuracy of SCD risk prediction of the 2011 ACCF/AHA and 2014 ESC guidelines, we will identify novel risk factors associated with the clinical outcomes and construct predictive models suitable for Chinese patients with HCM.
- Conditions
- Cardiomyopathy, Hypertrophic
- Keywords
- hypertrophic cardiomyopathy, clinical outcomes, multi-omics, risk stratification
- Medical subject headings
- Cardiomyopathy, Hypertrophic
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 |
|---|---|---|
| Hypertrophic cardiomyopathy | Individuals with an unexplained maximal left ventricle wall thickness ≥15 mm on echocardiography and/or cardiac magnetic resonance imaging or or ≥13 mm for individuals with family history of HCM, in the absence of other cardiac or systemic diseases capable of producing that magnitude of cardiac hypertrophy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular deaths
Including SCD and deaths due to heart failure and stroke.
Measured: an average of 2 years
Secondary outcomes (4)
all-cause mortality
deaths due to all causes.
Measured: an average of 2 years.
Heart failure
Progress to level III or IV in New York Heart Association class.
Measured: an average of 2 years
Stroke
including cerebral infarction and hemorrhage
Measured: an average of 2 years
Malignant arrhythmia
The incidence rate of malignant arrhythmia
Measured: an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study start23 Mar 2011
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy, HypertrophicStudies of the same condition, open and under way.
- 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lei.Song@NCCD, China National Center for Cardiovascular Diseases
- Investigators
- Song Lei, MD.&ph.D, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696135
- Sponsor's protocol ID
- CHCS
- Acronym
- CHCS
- Status last verified
- Mar 2018
- First submitted
- 26 Jan 2016
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chinese Hypertrophic Cardiomyopathy Study(CHCS)
- ClinicalTrials.gov ID
- NCT02696135
- Acronym / sponsor ID
- CHCS / CHCS
- Conditions
- Cardiomyopathy, Hypertrophic
- Keywords
- hypertrophic cardiomyopathy, clinical outcomes, multi-omics, risk stratification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 23 Mar 2011 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Mar 2016 (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.
Hypertrophic cardiomyopathy (HCM) is one of the most common inherited cardiac diseases, with a prevalence of ∼0.2%. Sudden cardiac death (SCD), heart failure and stroke are the major poor outcomes of HCM. Although about half of the patients were found to be caused by mutations mainly located in genes encoding sarcomere proteins, the causes in a significant proportion of patients with HCM are still unknown. Even in the patients with sarcomere mutations, the molecular pathways that eventually lead to cardiac hypertrophy are remained to be revealed. Furthermore, HCM presents with significant heterogeneity. SCD risk stratification and prevention by ICD are necessary. However, the strategy of SCD risk stratification recommended by the 2011 ACCF/AHA and 2014 ESC guidelines were based mainly on the evidence derived from American and European countries. The accuracy of these guidelines in Chines patients with HCM was not evaluated yet.
Detailed description
In the present study, patients with HCM are recruited prospectively after informed consent was given. The investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hr Holter, echocardiography, MRI and other examinations if necessary. The specimens retained include blood for all patients and myocardium for patients receive surgery of myocardial myectomy. Multi-omics screening, including genomics, epigenomics, transcriptomics, proteomics, metabolomics, will be performed to identified novel disease genes, signal pathway or processes, genetic risk factors and potential therapy targets of HCM. Furthermore, besides examining the accuracy of SCD risk prediction of the 2011 ACCF/AHA and 2014 ESC guidelines, we will identify novel risk factors associated with the clinical outcomes and construct predictive models suitable for Chinese patients with HCM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertrophic cardiomyopathy | – | –Individuals with an unexplained maximal left ventricle wall thickness ≥15 mm on echocardiography and/or cardiac magnetic resonance imaging or or ≥13 mm for individuals with family history of HCM, in the absence of other cardiac or systemic diseases capable of producing that magnitude of cardiac hypertrophy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with HCM are recruited from multiple centers in China between March 23, 2016 and December 31, 2025.
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
Cardiovascular deaths
Time frame: an average of 2 years
Including SCD and deaths due to heart failure and stroke.
4 secondary outcomes
all-cause mortality
Time frame: an average of 2 years.
Heart failure
Time frame: an average of 2 years
Stroke
Time frame: an average of 2 years
Malignant arrhythmia
Time frame: an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Song Lei, MD.&ph.D principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
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 Cardiomyopathy, Hypertrophic, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2018. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Song Lei, MD.&ph.D (86-13810532620, clinicalfw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular deaths (time frame: an average of 2 years). 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 27 Mar 2018.