Early Myocardial Dysfunction Helps Identify Severe Refrac... | NCT07425730

Studies
Early Myocardial Dysfunction Helps Identify Severe Refractory Pediatric Lupus

NCT07425730

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Recruiting

Last Update Posted

Apr 28, 2026Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Systemic Lupus Erythematosus (SLE)

Interventions

Not provided

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

ID	Type	Description	Link
ELYZX202102	Other Grant/Funding Number	School of Pediatrics, School of Medicine, Shanghai

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2026Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 1, 2026Estimated

First Submitted Date

Feb 6, 2026

First Submission Date that Met QC Criteria

Feb 20, 2026

First Posted Date

Feb 23, 2026Actual

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

Apr 22, 2026

Last Update Posted Date

Apr 28, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shengfang Bao, Principal Investigator, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To investigate biomarkers to identify pediatric SR-SLE patients by non-invasive echocardiographic techniques.

Detailed Description

Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease. Although therapeutic advances have improved outcomes, a significant subset remains with severe disease activity despite optimal therapy, which is recognized as the severe refractory SLE (SR-SLE).A recent study using advanced echocardiographic techniques of global longitudinal strain (GLS) have revealed that left ventricular dysfunction is common in SLE patients and correlates with disease severity.The finding underscores the potential role of early myocardial dysfunction as a phenotypic marker of SR-SLE.To our knowledge, there are no validated biomarkers to reliably identify patients with SR-SLE at an early stage, especially in the pediatric population. Therefore, this study aimed to investigate biomarkers to identify pediatric SR-SLE patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
children with SLE		Pediatric patients fulfilled the American College of Rheumatology (ACR) criteria with disease onset at ages before 18 years。

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
echocardiographic measurements	echocardiographic measurements including chamber dimensions, LV systolic and diastolic function, valve disease, strain values and etc..	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

fulfill the American College of Rheumatology (ACR) criteria
disease onset at ages before 18 years

Exclusion Criteria:

patients with a history of concomitant malignancy
patients with active bacterial, viral, fungal, mycobacterial infection

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

pediatric lupus patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bao	Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Children's Medical Center	Recruiting	Shanghai	Shanghai Municipality	200127	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Participant informed consent is limited to this specific analysis and does not include provisions for broad sharing in public databases.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008180	Lupus Erythematosus, Systemic

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided