[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657270":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":36,"studyPopulation":37,"armGroups":38,"interventions":32,"overallOfficials":48,"centralContacts":53,"locations":32,"responsibleParty":59,"collaborators":32,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":32,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":32,"enrollmentInfo":72,"targetDuration":32,"studyType":75,"phases":32,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":87,"whyStopped":32,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":32},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Correlation Between Echocardiographic Diastolic Parameters and Inflammatory Biomarkers","Correlation coefficient between echocardiographic parameters of left ventricular diastolic dysfunction (E\u002FA ratio, e', E\u002Fe' 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.","Baseline (at ICU admission)",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"Mean E\u002FA Ratio","Mean early-to-late diastolic filling velocity ratio (E\u002FA) measured by transthoracic echocardiography.",{"measure":18,"description":19,"timeFrame":12},"Mean E\u002Fe' Ratio","Mean ratio of early mitral inflow velocity to early diastolic mitral annular velocity (E\u002Fe') measured by tissue Doppler echocardiography.",{"measure":21,"description":22,"timeFrame":12},"Mean Left Atrial Volume Index (LAVI)","Mean left atrial volume index in mL\u002Fm² measured by transthoracic echocardiography.",{"measure":24,"description":25,"timeFrame":12},"Mean C-Reactive Protein (CRP) Level","Mean serum C-reactive protein level in mg\u002FL measured by immunoturbidimetry.",{"measure":27,"description":28,"timeFrame":12},"Mean Neutrophil-to-Lymphocyte Ratio (NLR)","Mean neutrophil-to-lymphocyte ratio calculated from complete blood count.",{"measure":30,"description":31,"timeFrame":12},"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.",null,{"allocation":32,"interventionModel":32,"interventionModelDescription":32,"primaryPurpose":32,"observationalModel":34,"timePerspective":35,"maskingInfo":32},"CASE_CONTROL","CROSS_SECTIONAL","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.\n\nLupus 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.\n\nThis 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.\n\nThis 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\u002FA ratio, e', E\u002Fe' 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.",[39,42,45],{"label":40,"type":32,"description":41,"interventionNames":32},"Control Group","Participants without SLE or lupus nephritis.",{"label":43,"type":32,"description":44,"interventionNames":32},"SLE without Lupus Nephritis","Patients diagnosed with SLE without lupus nephritis.",{"label":46,"type":32,"description":47,"interventionNames":32},"SLE with Lupus Nephritis","Patients diagnosed with SLE and biopsy-proven or clinically diagnosed lupus nephritis.",[49],{"name":50,"affiliation":51,"role":52},"sohair m kasim, prof","Critical Care Unit Department of Internal Medicine, Assiut University Hospital, Assiut, Egypt","STUDY_CHAIR",[54],{"name":55,"role":56,"phone":57,"phoneExt":32,"email":58},"Alaa M Abdelaal, Resident","CONTACT","01156604132","Alaa.18313526@med.aun.edu.eg",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Alaa Mohamed Abdelmohsen Abdelaal","Resident Physician, Department of Internal Medicine","100657270","diastolic-dysfunction-and-inflammatory-biomarkers-in-lupus-nephritis-100657270",false,"NCT07837544","Diastolic Dysfunction and Inflammatory Biomarkers in Lupus Nephritis","Correlation Between Echocardiographic Parameters of Left Ventricular Diastolic Dysfunction and Inflammatory Biomarkers in Critically Ill Patients With Lupus Nephritis","Inclusion Criteria:\n\nAdult patients ≥ 18 years\n\n* Patients diagnosed with Systemic Lupus Erythematosus fulfilling the 2019 EULAR\u002FACR criteria\n* Biopsy-proven or clinically diagnosed lupus nephritis admitted to the intensive care unit (ICU), regardless of the primary cause of admission\n* Patients who provided informed consent to undergo echocardiographic assessment and blood sampling for inflammatory biomarkers\n\nExclusion Criteria:\n\n* Pediatric patients \\\u003C 18 years\n\n  * Patients with pre-existing primary cardiac disease unrelated to SLE (e.g., congenital heart disease, valvular heart disease, ischemic heart disease, cardiomyopathy)\n  * Patients with poor echocardiographic acoustic window precluding adequate assessment of diastolic function\n  * Patients with atrial fibrillation or other significant arrhythmias affecting Doppler-derived diastolic parameters\n  * Patients with chronic kidney disease stage 5 on maintenance dialysis prior to the current critical illness\n  * Patients with active sepsis-induced cardiomyopathy or septic shock where hemodynamic instability may confound diastolic function assessmentdiastolic function assessment.","ALL","18 Years",{"count":73,"type":74},90,"ESTIMATED","OBSERVATIONAL","This cross-sectional observational study aims to investigate the correlation between echocardiographic parameters of left ventricular diastolic dysfunction (E\u002FA ratio, e', E\u002Fe' 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.",[78,79,80,81],"Lupus Nephritis","Diastolic Dysfunction","Systemic Lupus Erythematosus","Heart Failure, Diastolic",[78,83,79,84,85,86],"Echocardiography","ESR","CRP","Critically Ill","NOT_YET_RECRUITING","2026-09-23",{"date":90,"type":91},"2026-09-24","ACTUAL",{"date":93,"type":74},"2026-09-20",{"date":95,"type":74},"2028-03-10",{"name":5,"class":6}]