Early Myocardial Dysfunction Helps Identify Severe Refractory Pediatric Lupus

April 22, 2026 updated by: Shengfang Bao, Shanghai Jiao Tong University School of Medicine

Myocardial Dysfunction in Pediatric Lupus

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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

pediatric lupus patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
children with SLE
Pediatric patients fulfilled the American College of Rheumatology (ACR) criteria with disease onset at ages before 18 years。

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Bao, Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELYZX202102 (Other Grant/Funding Number: School of Pediatrics, School of Medicine, Shanghai)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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