An observational study in Lupus Nephritis, Diastolic Dysfunction and Systemic Lupus Erythematosus, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Assiut University · Observational
Among 22 studies in Lupus Nephritis by Assiut University — 17 open to participants now, 17 under way, none of them phase 3. Lupus Nephritis · Assiut University.
Among the 22 studies in Lupus Nephritis by Assiut University, this one is the 12th largest by planned enrollment of the 21 observational ones, is one of 8 that started in 2026, is one of 21 observational ones, reaches primary completion later than 12 of the 16 other live ones, and was the 22nd registered.
340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.
This study's planned enrollment of 90 is close to the median of 100 across 77 observational studies indexed under Lupus Nephritis.
Browse Lupus Nephritis studies →17 of the 22 studies in Lupus Nephritis by Assiut University are open now, in 1 country. Each count lists the studies.
Of the 88 Lupus Nephritis studies recruiting now, 30 (34%) set no upper age limit and 51 (58%) stop at 75 or younger; 29 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 8 started in 2026.
Median enrollment 60 across the 1 interventional studies, 96 across the 21 observational. None of them has completed or been terminated yet.
Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
7 of the studies in Lupus Nephritis by Assiut University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06564181Assiut UniversityThe Relation Between Serum Zinc and Lupus Nephritis | 2026-12 |
| NCT07505576Assiut UniversityAnti-alpha-actinin Antibodies and Lupus Nephritis Activity | 2027-04-01 |
| NCT06837558Assiut UniversityPredictors of Bone Mineral Density in Lupus Nephritis Activity | 2027-04-01 |
| NCT07780045Assiut UniversitySII and SIRI as Prognostic Biomarkers in Lupus Nephritis | 2027-08-19 |
| NCT07837544Assiut UniversityDiastolic Dysfunction and Inflammatory Biomarkers in Lupus Nephritis | 2027-09-20 |
Among the 22 studies in Lupus Nephritis by Assiut University, from their registry updates:
Nothing recorded among them since 2026-09-25.
This cross-sectional observational study aims to investigate the correlation between echocardiographic parameters of left ventricular diastolic dysfunction (E/A ratio, e', E/e' ratio, LAVI, and LVEF) and systemic inflammatory biomarkers (CRP, ESR, NLR, PLR, and SII) in critically ill patients with lupus nephritis. A total of 90 participants will be enrolled and divided into three groups: control group without SLE or lupus nephritis (n=30), SLE without lupus nephritis (n=30), and SLE with lupus nephritis (n=30). Transthoracic echocardiography and blood sampling for inflammatory biomarkers will be performed at baseline (ICU admission). The findings may help evaluate the potential role of these biomarkers in early cardiac risk assessment in this patient population.
Lupus nephritis is a frequent and severe manifestation of systemic lupus erythematosus (SLE) and often develops early in the disease course. Its pathophysiology is heterogeneous, driven by genetic, environmental, and immune-mediated mechanisms that produce inflammatory kidney injury. Despite therapeutic advances, lupus nephritis remains a major cause of chronic kidney disease, end-stage kidney disease, death, and reduced quality of life.
Lupus nephritis can promote heart failure through intertwined inflammatory, renal, vascular, and hemodynamic pathways. Patients with SLE have increased heart failure risk, and cardiovascular risk is higher when nephritis is present. Renal impairment and proteinuria in lupus nephritis are linked to hypertension, dyslipidemia, endothelial dysfunction, and prothrombotic tendency, which can accelerate myocardial remodeling and dysfunction. Lupus nephritis directly causes diastolic heart failure through systemic inflammation and immune-complex deposition that produce interstitial myocardial fibrosis, edema, and diastolic dysfunction.
This study addresses an important gap in patients with lupus nephritis, where subclinical myocardial dysfunction is increasingly recognized but poorly characterized in critically ill patients. Echocardiographic and tissue Doppler abnormalities correlate with inflammatory biomarkers such as CXCL10 and sST2 in SLE. Lupus nephritis is also associated with more severe myocardial involvement and higher inflammatory burden than extra-renal disease. However, adult intensive-care data linking left ventricular diastolic dysfunction parameters with systemic inflammatory biomarkers in lupus nephritis remain limited.
This cross-sectional observational study will enroll 90 participants divided into three groups: control group without SLE or lupus nephritis (n=30), SLE without lupus nephritis (n=30), and SLE with lupus nephritis (n=30). Participants will undergo comprehensive clinical assessment, transthoracic echocardiography to assess left ventricular diastolic function (E/A ratio, e', E/e' ratio, LAVI, and LVEF), and blood sampling for inflammatory biomarkers (CRP, ESR, NLR, PLR, and SII). Disease activity will be assessed using the SLEDAI-2K score, and renal function will be assessed by eGFR and CKD stage. The correlation between echocardiographic diastolic parameters and inflammatory biomarkers will be determined, and independent predictors of diastolic dysfunction will be identified.
Adult patients (≥18 years) admitted to the Critical Care Unit and Rheumatology Unit at Assiut University Hospital, including patients with SLE with or without lupus nephritis, and control participants without SLE or lupus nephritis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adult patients ≥ 18 years
Exclusion Criteria:
Pediatric patients \< 18 years
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants without SLE or lupus nephritis.
Patients diagnosed with SLE without lupus nephritis.
Patients diagnosed with SLE and biopsy-proven or clinically diagnosed lupus nephritis.
Correlation Between Echocardiographic Diastolic Parameters and Inflammatory Biomarkers
Correlation coefficient between echocardiographic parameters of left ventricular diastolic dysfunction (E/A ratio, e', E/e' ratio, LAVI, and LVEF) and systemic inflammatory biomarkers (CRP and ESR) in critically ill patients with lupus nephritis, assessed by Pearson's or Spearman's correlation coefficient.
Time frame: Baseline (at ICU admission)
Mean E/A Ratio
Mean early-to-late diastolic filling velocity ratio (E/A) measured by transthoracic echocardiography.
Time frame: Baseline (at ICU admission)
Mean E/e' Ratio
Mean ratio of early mitral inflow velocity to early diastolic mitral annular velocity (E/e') measured by tissue Doppler echocardiography.
Time frame: Baseline (at ICU admission)
Mean Left Atrial Volume Index (LAVI)
Mean left atrial volume index in mL/m² measured by transthoracic echocardiography.
Time frame: Baseline (at ICU admission)
Mean C-Reactive Protein (CRP) Level
Mean serum C-reactive protein level in mg/L measured by immunoturbidimetry.
Time frame: Baseline (at ICU admission)
Mean Neutrophil-to-Lymphocyte Ratio (NLR)
Mean neutrophil-to-lymphocyte ratio calculated from complete blood count.
Time frame: Baseline (at ICU admission)
Mean SLEDAI-2K Score
Mean Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score. Scores range from 0 to 105, with higher scores indicating greater disease activity.
Time frame: Baseline (at ICU admission)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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