Hypertrophic Cardiomyopathy (HCM)NCT07638033
A Real-world HCM-cohort Trial
An observational study of Hypertrophic Cardiomyopathy (HCM), run by Xijing Hospital at 1 site in China.
Trial summary
Hypertrophic cardiomyopathy (HCM) is a genetically mediated myocardial disease predominantly caused by pathogenic mutations in sarcomeric protein genes and characterized by asymmetric left ventricular hypertrophy. Patients with HCM commonly present with dyspnea, chest pain, and exercise intolerance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertrophic Cardiomyopathy (HCM)
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 31 Dec 2030
- How long will I take part?
- 3 Years
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: An expected enrollment of 3,000 HCM patients will be enrolled within the next 2 years.
Who may be able to join
- Meet the clinical diagnostic criteria for HCM*;
- Patients who understand the purpose of this study, voluntarily participate in the trial and sign the informed consent form, have good compliance, and are willing to undergo clinical follow-up.
- Clinical diagnosis of HCM is defined as left ventricular wall thickness ≥15mm at any position during diastole by.echocardiography or CMR (≥13mm if there is a family history of HCM or positive cardiac genetic testing), and other secondary factors (such as severe hepertension, aortic stenosis) causing myocardial hypertrophy are excluded.
Who cannot join
- Metabolic syndrome or hypertrophic cardiomyopathy-like syndromes associated with left ventricular hypertrophy, such as amyloid cardiomyopathy, sarcoidosis, Fabry disease, Danon disease or Noonan syndrome;
- Severe systemic hypertension and/or severe aortic stenosis (<1cm²);
- Comorbid malignant tumors;
- Comorbid with other end-stage diseases with an expected lifespan of less than 3 years;
- Comorbid with mental disorders;
- Currently participating in other clinical trials and not reaching the primary endpoint.
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
the First Affiliated Hospital of the Air Force Medical University
Xi'an, China/Shaan XI Province
About this study
Official title: A Multicenter, Prospective, Real-world Study on Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is a genetically mediated myocardial disease predominantly caused by pathogenic mutations in sarcomeric protein genes and characterized by asymmetric left ventricular hypertrophy. Patients with HCM commonly present with dyspnea, chest pain, and exercise intolerance. Sudden cardiac death, progressive heart failure, and thromboembolic events remain the leading causes of mortality and morbidity, substantially impairing quality of life and increasing healthcare burden.
Despite advances in understanding the pathophysiology, diagnosis, and management of HCM, significant challenges persist, including etiological heterogeneity and underdiagnosis. At present, dedicated and systematic HCM databases remain lacking in China. Establishing a nationally HCM cohort and disease-specific database is therefore of considerable importance. In alignment with the goals of the "Healthy China 2030" initiative and supported by advances in medical big data technologies.
This study aims to construct a comprehensive HCM cohort, evaluate contemporary diagnostic and therapeutic practices and patient prognosis, identify relevant risk factors, and ultimately improve the overall management of patients with HCM.
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Being tested
- Standard of care
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careDrug
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Hypertrophic cardiomyopathy | Patients who meet the clinical diagnostic criteria for hypertrophic cardiomyopathy. Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
The primary outcome was major adverse cardiovascular events (MACE), defined as a composite of cardiac death, ischemic stroke, systemic embolism, malignant arrhythmia events, non-fatal myocardial infarction, and rehospitalization for heart failure.
Measured: 1, 6, 12, 24, 36, 60 months
Secondary outcomes (15)
Cardiac death
Incidence of individual components of MACE.
Measured: 1, 6, 12, 24, 36, 60 months
Ischemic stroke
Incidence of individual components of MACE.
Measured: 1, 6, 12, 24, 36, 60 months
Systemic embolism
Incidence of individual components of MACE.
Measured: 1, 6, 12, 24, 36, 60 months
Malignant arrhythmia events
Incidence of individual components of MACE.
Measured: 1, 6, 12, 24, 36, 60 months
Non-fatal myocardial infarction
Incidence of individual components of MACE.
Measured: 1, 6, 12, 24, 36, 60 months
Rehospitalization for heart failure.
Incidence of individual components of MACE.
Measured: 1, 6, 12, 24, 36, 60 months
All-cause mortality
Incidence of all-cause mortality.
Measured: 1, 6, 12, 24, 36, 60 months
Number of rehospitalizations for heart failure
Total number of rehospitalizations for heart failure during follow-up.
Measured: 1, 6, 12, 24, 36, 60 months
New-onset atrial arrhythmias
Incidence of new-onset atrial arrhythmias, including atrial tachycardia, atrial flutter, and atrial fibrillation.
Measured: 1, 6, 12, 24, 36, 60 months
End-stage heart failure
Incidence of end-stage heart failure.
Measured: 1, 6, 12, 24, 36, 60 months
Heart transplantation
Incidence of heart transplantation.
Measured: 1, 6, 12, 24, 36, 60 months
Non-obstructive hypertrophic cardiomyopathy progressing to obstructive hypertrophic cardiomyopathy
Incidence of non-obstructive hypertrophic cardiomyopathy progressing to obstructive hypertrophic cardiomyopathy.
Measured: 1, 6, 12, 24, 36, 60 months
Anxiety/depressive mental disorders
Incidence of anxiety/depressive mental disorders.
Measured: 1, 6, 12, 24, 36, 60 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ) ≥5-point improvement
Proportion of patients achieving a ≥5-point improvement in KCCQ score from baseline after treatment. The KCCQ Overall Summary Score ranges from 0 to 100, with higher scores indicating better health status.A ≥5-point increase is considered a clinically meaningful improvement.
Measured: 1, 6, 12, 24, 36, 60 months
BARC 3 or 5 bleeding
Incidence of BARC 3 or 5 bleeding.
Measured: [1, 6, 12, 24, 36, 60 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Cardiomyopathy (HCM)Studies 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)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Tao, MD, PhD, Xijing Hospital
- Investigators
- Ling Tao, MD, Ph.D, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638033
- Sponsor's protocol ID
- KY20262041-C-1
- Status last verified
- Jun 2026
- First submitted
- 23 Feb 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Real-world Study on Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07638033
- Acronym / sponsor ID
- KY20262041-C-1
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 10 Jun 2026 (actual)
- 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 a genetically mediated myocardial disease predominantly caused by pathogenic mutations in sarcomeric protein genes and characterized by asymmetric left ventricular hypertrophy. Patients with HCM commonly present with dyspnea, chest pain, and exercise intolerance. Sudden cardiac death, progressive heart failure, and thromboembolic events remain the leading causes of mortality and morbidity, substantially impairing quality of life and increasing healthcare burden.
Despite advances in understanding the pathophysiology, diagnosis, and management of HCM, significant challenges persist, including etiological heterogeneity and underdiagnosis. At present, dedicated and systematic HCM databases remain lacking in China. Establishing a nationally HCM cohort and disease-specific database is therefore of considerable importance. In alignment with the goals of the "Healthy China 2030" initiative and supported by advances in medical big data technologies.
This study aims to construct a comprehensive HCM cohort, evaluate contemporary diagnostic and therapeutic practices and patient prognosis, identify relevant risk factors, and ultimately improve the overall management of patients with HCM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertrophic cardiomyopathy | – | Drug: Standard of carePatients who meet the clinical diagnostic criteria for hypertrophic cardiomyopathy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- An expected enrollment of 3,000 HCM patients will be enrolled within the next 2 years.
Key inclusion criteria (3 listed)
- Meet the clinical diagnostic criteria for HCM*;
- Patients who understand the purpose of this study, voluntarily participate in the trial and sign the informed consent form, have good compliance, and are willing to undergo clinical follow-up.
Key exclusion criteria (6 listed)
- Metabolic syndrome or hypertrophic cardiomyopathy-like syndromes associated with left ventricular hypertrophy, such as amyloid cardiomyopathy, sarcoidosis, Fabry disease, Danon disease or Noonan syndrome;
- Severe systemic hypertension and/or severe aortic stenosis (<1cm²);
- Comorbid malignant tumors;
- Comorbid with other end-stage diseases with an expected lifespan of less than 3 years;
- Comorbid with mental disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careStandard of care | Drug | Hypertrophic cardiomyopathy |
Primary outcome
MACE
Time frame: 1, 6, 12, 24, 36, 60 months
The primary outcome was major adverse cardiovascular events (MACE), defined as a composite of cardiac death, ischemic stroke, systemic embolism, malignant arrhythmia events, non-fatal myocardial infarction, and rehospitalization for heart failure.
15 secondary outcomes
Cardiac death
Time frame: 1, 6, 12, 24, 36, 60 months
Ischemic stroke
Time frame: 1, 6, 12, 24, 36, 60 months
Systemic embolism
Time frame: 1, 6, 12, 24, 36, 60 months
Malignant arrhythmia events
Time frame: 1, 6, 12, 24, 36, 60 months
Non-fatal myocardial infarction
Time frame: 1, 6, 12, 24, 36, 60 months
Rehospitalization for heart failure.
Time frame: 1, 6, 12, 24, 36, 60 months
All-cause mortality
Time frame: 1, 6, 12, 24, 36, 60 months
Number of rehospitalizations for heart failure
Time frame: 1, 6, 12, 24, 36, 60 months
New-onset atrial arrhythmias
Time frame: 1, 6, 12, 24, 36, 60 months
End-stage heart failure
Time frame: 1, 6, 12, 24, 36, 60 months
Heart transplantation
Time frame: 1, 6, 12, 24, 36, 60 months
Non-obstructive hypertrophic cardiomyopathy progressing to obstructive hypertrophic cardiomyopathy
Time frame: 1, 6, 12, 24, 36, 60 months
Anxiety/depressive mental disorders
Time frame: 1, 6, 12, 24, 36, 60 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ) ≥5-point improvement
Time frame: 1, 6, 12, 24, 36, 60 months
BARC 3 or 5 bleeding
Time frame: [1, 6, 12, 24, 36, 60 months]
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 10 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Ling Tao, MD, Ph.D study chair
Xijing 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 Hypertrophic Cardiomyopathy (HCM), run by Xijing Hospital at 1 site in China.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Jun 2026. 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 Lanyan Guo, MD, Ph.D (+86-18189145929, guolany@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 1, 6, 12, 24, 36, 60 months). 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 10 Jun 2026.