Hypertrophic Cardiomyopathy (HCM)NCT07336290
One-stop Evaluation of Hypertrophic Cardiomyopathy in Cardiac Magnetic Resonance
An observational study of Hypertrophic Cardiomyopathy (HCM), run by Minjie Lu.
Trial summary
This is a multi-center, observational study aiming to establish a precision diagnosis scheme and multi-dimensional risk prediction models for Hypertrophic Cardiomyopathy (HCM). The study plans to enroll 10000 adult HCM patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertrophic Cardiomyopathy (HCM)
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 30 Dec 2030
- 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: patients with hypertrophic myocardium experienced CMR scanning
Who may be able to join
- A maximal left ventricular wall thickness of ≥ 12 mm in any segment at end-diastole, as measured by echocardiography or Cardiac Magnetic Resonance (CMR)
Who cannot join
- Presence of any contraindication to CMR examination.
- Unwillingness to participate in the study or to provide informed consent.
About this study
This is a multi-center, observational study aiming to establish a precision diagnosis scheme and multi-dimensional risk prediction models for Hypertrophic Cardiomyopathy (HCM). The study plans to enroll 10000 adult HCM patients. It will integrate genetic testing, advanced cardiac imaging (echocardiography and cardiac magnetic resonance), and biomarker analysis to develop early diagnosis, differential diagnosis, and new risk prediction models for sudden cardiac death (SCD) and heart failure in HCM patients. Participants will undergo baseline assessments and be followed up every six months for up to 3 years to track clinical outcomes. This study is non-interventional and does not involve any investigational drugs or devices.
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Keywords
- cardiac magnetic resonance, diagnosis, risk stratificaiton, artificial intelligence, personalized prognosis
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Disease
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 myocardium | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with sudden cardiac death
Measured: 5-year
Secondary outcomes (3)
Number of participants with all-cause mortality
Measured: 5-year
Number of participants with atrial fibrillation
Measured: 5-year
Number of participants with heart failure hospitalization
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jan 2010
- Primary completion30 Jul 2028 (estimated)
- Study completion30 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
- Other
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minjie Lu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336290
- Sponsor's protocol ID
- One-stop HCM
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-stop Evaluation of Hypertrophic Cardiomyopathy in Cardiac Magnetic Resonance
- ClinicalTrials.gov ID
- NCT07336290
- Acronym / sponsor ID
- One-stop HCM
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Keywords
- cardiac magnetic resonance, diagnosis, risk stratificaiton, artificial intelligence, personalized prognosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Minjie LuUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 13 Jan 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.
This is a multi-center, observational study aiming to establish a precision diagnosis scheme and multi-dimensional risk prediction models for Hypertrophic Cardiomyopathy (HCM). The study plans to enroll 10000 adult HCM patients. It will integrate genetic testing, advanced cardiac imaging (echocardiography and cardiac magnetic resonance), and biomarker analysis to develop early diagnosis, differential diagnosis, and new risk prediction models for sudden cardiac death (SCD) and heart failure in HCM patients. Participants will undergo baseline assessments and be followed up every six months for up to 3 years to track clinical outcomes. This study is non-interventional and does not involve any investigational drugs or devices.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypertrophic myocardium | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with hypertrophic myocardium experienced CMR scanning
Key inclusion criteria (1 listed)
- A maximal left ventricular wall thickness of ≥ 12 mm in any segment at end-diastole, as measured by echocardiography or Cardiac Magnetic Resonance (CMR)
Key exclusion criteria (2 listed)
- Presence of any contraindication to CMR examination.
- Unwillingness to participate in the study or to provide informed consent.
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
Number of participants with sudden cardiac death
Time frame: 5-year
3 secondary outcomes
Number of participants with all-cause mortality
Time frame: 5-year
Number of participants with atrial fibrillation
Time frame: 5-year
Number of participants with heart failure hospitalization
Time frame: 5-year
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 28 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy (HCM), run by Minjie Lu.
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 1 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: enrolling by invitation, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Number of participants with sudden cardiac death (time frame: 5-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 28 Jan 2026.