SMCs With LVH Compared to HCM | NCT07006974

Studies
SMCs With LVH Compared to HCM

NCT07006974

Sponsor

China National Center for Cardiovascular Diseases

Status

Active, not recruiting

Last Update Posted

Jan 8, 2026Actual

Enrollment

165Estimated

Phase

Not provided

Conditions

Syndromic and Metabolic Cardiomyopathy
Cardiomyopathies

Interventions

SMCs

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 27, 2025Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

May 28, 2025

First Submission Date that Met QC Criteria

May 28, 2025

First Posted Date

Jun 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2026

Last Update Posted Date

Jan 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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?

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

165Estimated

Name	Type	Description	Arm Group Labels	Other Names
SMCs	Other	patients with SMCs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

incomplete baseine data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Liang	Chinese Academy of Medical Sciences, Fuwai Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fuwai Hospital, Chinese Academy of Medical Sciences		Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009202	Cardiomyopathies

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided