Early heart muscle changes to spot severe pediatric lupus
Myocardial Dysfunction in Pediatric Lupus
This project will test whether non-invasive heart ultrasound measurements can help identify children with severe, treatment-resistant lupus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07425730 on ClinicalTrials.gov |
What this trial studies
This observational study uses advanced echocardiography, including global longitudinal strain (GLS), together with clinical data and biomarkers to detect early myocardial dysfunction in pediatric SLE. Eligible participants are children whose disease began before age 18 and who meet American College of Rheumatology criteria, with exclusions for malignancy or active infections. Investigators will compare echocardiographic measures to clinical severity to see if early heart changes mark severe refractory disease. The work is conducted at Shanghai Children's Medical Center and does not involve experimental treatments.
Who should consider this trial
Good fit: Children with SLE onset before age 18 who meet ACR criteria and do not have concurrent malignancy or active infection are the ideal candidates.
Not a fit: Patients with a history of cancer, active infections, adult-onset SLE, or whose heart imaging does not show dysfunction are unlikely to benefit directly from the findings.
Why it matters
Potential benefit: If successful, this could allow earlier identification of children with severe refractory SLE so clinicians can intensify monitoring and tailor treatments sooner.
How similar studies have performed: Prior studies using GLS have shown left ventricular dysfunction is common in SLE and correlates with disease severity, but no validated biomarkers for early identification of pediatric SR-SLE currently exist.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Children's Medical Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Bao — Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.