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Recruiting

NCT Number: NCT07425730

Early Myocardial Dysfunction Helps Identify Severe Refractory Pediatric Lupus

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

Recruiting

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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. echocardiographic measurements

    Time frame: 6 months

    echocardiographic measurements including chamber dimensions, LV systolic and diastolic function, valve disease, strain values and etc..

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Myocardial Dysfunction in Pediatric Lupus

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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