Early Myocardial Dysfunction Helps Identify Severe Refractory Pediatric Lupus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erythematosus (SLE). Basic parameters: 7 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Myocardial Dysfunction in Pediatric Lupus
Overview
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.
Primary outcome measures
- echocardiographic measurements [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai Children's Medical Center — Shanghai
Identifiers
NCT: NCT07425730 · ELYZX202102 · ELYZX202102