Systemic Lupus Erythematosus (SLE)NCT07425730
Early Myocardial Dysfunction Helps Identify Severe Refractory Pediatric Lupus
An observational study of Systemic Lupus Erythematosus (SLE), run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To investigate biomarkers to identify pediatric SR-SLE patients by non-invasive echocardiographic techniques. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Jul 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: pediatric lupus patients
Who may be able to join
- fulfill the American College of Rheumatology (ACR) criteria
- disease onset at ages before 18 years
Who cannot join
- patients with a history of concomitant malignancy
- patients with active bacterial, viral, fungal, mycobacterial infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, 200127
Shengfang Bao, 13671722163, 13671722163@163.com
Yuqi Zhang, 18930380816, zhangyuqi@scmc.com.cn
About this study
Official title: Myocardial Dysfunction in Pediatric Lupus
To investigate biomarkers to identify pediatric SR-SLE patients by non-invasive echocardiographic techniques.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Keywords
- lupus, echocardiography
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| children with SLE | Pediatric patients fulfilled the American College of Rheumatology (ACR) criteria with disease onset at ages before 18 years。 |
What is being measured
The primary outcome is the main question the study is designed to answer.
echocardiographic measurements
echocardiographic measurements including chamber dimensions, LV systolic and diastolic function, valve disease, strain values and etc..
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Feb 2026
- Primary completionJul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengfang Bao, Shanghai Jiao Tong University School of Medicine
- Investigators
- Bao, Principal investigator, Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425730
- Sponsor's protocol ID
- ELYZX202102
- Other IDs
- ELYZX202102
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participant informed consent is limited to this specific analysis and does not include provisions for broad sharing in public databases.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Dysfunction in Pediatric Lupus
- ClinicalTrials.gov ID
- NCT07425730
- Acronym / sponsor ID
- ELYZX202102
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Keywords
- lupus, echocardiography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with SLE | – | –Pediatric patients fulfilled the American College of Rheumatology (ACR) criteria with disease onset at ages before 18 years。 |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- pediatric lupus patients
Key inclusion criteria (2 listed)
- fulfill the American College of Rheumatology (ACR) criteria
- disease onset at ages before 18 years
Key exclusion criteria (2 listed)
- patients with a history of concomitant malignancy
- patients with active bacterial, viral, fungal, mycobacterial infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
echocardiographic measurements
Time frame: 6 months
echocardiographic measurements including chamber dimensions, LV systolic and diastolic function, valve disease, strain values and etc..
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Undecided. Participant informed consent is limited to this specific analysis and does not include provisions for broad sharing in public databases.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bao principal investigator
Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus (SLE), run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
echocardiographic measurements (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.