Syndromic and Metabolic CardiomyopathyNCT07006974
SMCs With LVH Compared to HCM
An observational study of Syndromic and Metabolic Cardiomyopathy and Cardiomyopathies, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The goal of this cohort study is to investigate the clinical characteristics of SMCs and to explore the difference in cardiovascular outcomes in comparison to age-, sex-, and admission year-matched HCM patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Syndromic and Metabolic Cardiomyopathy, Cardiomyopathies
- What is being tested?
- SMCs
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2025to 1 Aug 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The investigators identified patients with SMCs by screening the electronic database. Gene testing and muscle biopsy were used to confirm the diagnosis of SMCs. (Part two) Patients with HCMs were included as the controls of SMCs who had LVH and available CMR data in our study. The diagnose of HCM was according to the 2024 ESC Guidelines of HCM but without evidence of SMCs. Controls were matched 1:2 to each case based on sex, age (matched within ± 5 years), and admission year (matched within ± 12 months).
Who may be able to join
- patients who were diagnosed SMCs or HCM. Gene testing and muscle biopsy were used to confirm the diagnosis of SMCs. The diagnose of HCM was according to the 2024 ESC Guidelines of HCM but without evidence of SMCs.
- complete baseline data
- accessible follow-up data
Who cannot join
- incomplete baseine data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients With Left Ventricular Hypertrophy in Syndromic and Metabolic Cardiomyopathy Compared to Hypertrophic Cardiomyopathy: an Age-sex Matched Cohort Study
The goal of this cohort study is to investigate the clinical characteristics of SMCs and to explore the difference in cardiovascular outcomes in comparison to age-, sex-, and admission year-matched HCM patients. The main question it aims to answer is:
- Do patients with SMCs have higher rates of cardiac outcomes?
- What risk factors do SMCs patients experience a poor prognosis?
- Being tested
- SMCs
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMCsOther
patients with SMCs
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome
a composite of all-cause death, hospitalization for heart failure, myocardial infarction, ischemia or hemorrhagic stroke (excluding transient ischemic attack), other thrombotic events, and modified International Society on Thrombosis and Haemostasis crit
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start27 May 2025
- Primary completion20 Jul 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syndromic and Metabolic CardiomyopathyStudies 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
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Liang, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006974
- Sponsor's protocol ID
- 2021-ZDYF-01-4
- Status last verified
- Jan 2026
- First submitted
- 28 May 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Left Ventricular Hypertrophy in Syndromic and Metabolic Cardiomyopathy Compared to Hypertrophic Cardiomyopathy: an Age-sex Matched Cohort Study
- ClinicalTrials.gov ID
- NCT07006974
- Acronym / sponsor ID
- 2021-ZDYF-01-4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 27 May 2025 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 5 Jun 2025 (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.
The goal of this cohort study is to investigate the clinical characteristics of SMCs and to explore the difference in cardiovascular outcomes in comparison to age-, sex-, and admission year-matched HCM patients. The main question it aims to answer is:
- Do patients with SMCs have higher rates of cardiac outcomes?
- What risk factors do SMCs patients experience a poor prognosis?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators identified patients with SMCs by screening the electronic database. Gene testing and muscle biopsy were used to confirm the diagnosis of SMCs. (Part two) Patients with HCMs were included as the controls of SMCs who had LVH and available CMR data in our study. The diagnose of HCM was according to the 2024 ESC Guidelines of HCM but without evidence of SMCs. Controls were matched 1:2 to each case based on sex, age (matched within ± 5 years), and admission year (matched within ± 12 months).
Key inclusion criteria (3 listed)
- patients who were diagnosed SMCs or HCM. Gene testing and muscle biopsy were used to confirm the diagnosis of SMCs. The diagnose of HCM was according to the 2024 ESC Guidelines of HCM but without evidence of SMCs.
- complete baseline data
- accessible follow-up data
Key exclusion criteria (1 listed)
- incomplete baseine data
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 |
|---|---|---|
| SMCspatients with SMCs | Other | – |
Primary outcome
primary outcome
Time frame: 3 years
a composite of all-cause death, hospitalization for heart failure, myocardial infarction, ischemia or hemorrhagic stroke (excluding transient ischemic attack), other thrombotic events, and modified International Society on Thrombosis and Haemostasis crit
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 26 Oct 2026.
- 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. This study is not recruiting at the moment.
Liang 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 Syndromic and Metabolic Cardiomyopathy and Cardiomyopathies, 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.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 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 26 Oct 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?
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?
primary outcome (time frame: 3 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 26 Oct 2026.