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
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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Alaa M Abdelaal, Resident
- Número de teléfono: 01156604132
- Correo electrónico: Alaa.18313526@med.aun.edu.eg
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
Inclusion Criteria:
Adult patients ≥ 18 years
- Patients diagnosed with Systemic Lupus Erythematosus fulfilling the 2019 EULAR/ACR criteria
- Biopsy-proven or clinically diagnosed lupus nephritis admitted to the intensive care unit (ICU), regardless of the primary cause of admission
- Patients who provided informed consent to undergo echocardiographic assessment and blood sampling for inflammatory biomarkers
Exclusion Criteria:
-
Pediatric patients < 18 years
- Patients with pre-existing primary cardiac disease unrelated to SLE (e.g., congenital heart disease, valvular heart disease, ischemic heart disease, cardiomyopathy)
- Patients with poor echocardiographic acoustic window precluding adequate assessment of diastolic function
- Patients with atrial fibrillation or other significant arrhythmias affecting Doppler-derived diastolic parameters
- Patients with chronic kidney disease stage 5 on maintenance dialysis prior to the current critical illness
- Patients with active sepsis-induced cardiomyopathy or septic shock where hemodynamic instability may confound diastolic function assessmentdiastolic function assessment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_CONTROL
- Perspectivas temporales: CROSS_SECTIONAL
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Control Group
Participants without SLE or lupus nephritis. |
|
SLE without Lupus Nephritis
Patients diagnosed with SLE without lupus nephritis. |
|
SLE with Lupus Nephritis
Patients diagnosed with SLE and biopsy-proven or clinically diagnosed lupus nephritis. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlation Between Echocardiographic Diastolic Parameters and Inflammatory Biomarkers
Periodo de tiempo: Baseline (at ICU admission)
|
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. |
Baseline (at ICU admission)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean E/A Ratio
Periodo de tiempo: Baseline (at ICU admission)
|
Mean early-to-late diastolic filling velocity ratio (E/A) measured by transthoracic echocardiography. |
Baseline (at ICU admission)
|
|
Mean E/e' Ratio
Periodo de tiempo: Baseline (at ICU admission)
|
Mean ratio of early mitral inflow velocity to early diastolic mitral annular velocity (E/e') measured by tissue Doppler echocardiography. |
Baseline (at ICU admission)
|
|
Mean Left Atrial Volume Index (LAVI)
Periodo de tiempo: Baseline (at ICU admission)
|
Mean left atrial volume index in mL/m² measured by transthoracic echocardiography. |
Baseline (at ICU admission)
|
|
Mean C-Reactive Protein (CRP) Level
Periodo de tiempo: Baseline (at ICU admission)
|
Mean serum C-reactive protein level in mg/L measured by immunoturbidimetry. |
Baseline (at ICU admission)
|
|
Mean Neutrophil-to-Lymphocyte Ratio (NLR)
Periodo de tiempo: Baseline (at ICU admission)
|
Mean neutrophil-to-lymphocyte ratio calculated from complete blood count. |
Baseline (at ICU admission)
|
|
Mean SLEDAI-2K Score
Periodo de tiempo: Baseline (at ICU admission)
|
Mean Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score. Scores range from 0 to 105, with higher scores indicating greater disease activity. |
Baseline (at ICU admission)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: sohair m kasim, prof, Critical Care Unit Department of Internal Medicine, Assiut University Hospital, Assiut, Egypt
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades cardiovasculares
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades cardíacas
- Atributos de la enfermedad
- Enfermedades del tejido conectivo
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Glomerulonefritis
- Nefritis
- Insuficiencia cardiaca
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de la piel y del tejido conectivo
- Lupus Eritematoso Sistémico
- Enfermedad crítica
- Nefritis lúpica
- Insuficiencia Cardíaca Diastólica
Otros números de identificación del estudio
- LN-DiastolicDysfunction-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .