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临床试验/NCT07837544
NCT07837544尚未招募不适用

Correlation Between Echocardiographic Parameters of Left Ventricular Diastolic Dysfunction and Inflammatory Biomarkers in Critically Ill Patients With Lupus Nephritis

Assiut University0 个研究点目标入组 90 人开始时间: 2026年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
主要终点
Correlation Between Echocardiographic Diastolic Parameters and Inflammatory Biomarkers

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

SLE without Lupus Nephritis

Patients diagnosed with SLE without lupus nephritis.

Control Group

Participants without SLE or lupus nephritis.

SLE with Lupus Nephritis

Patients diagnosed with SLE and biopsy-proven or clinically diagnosed lupus nephritis.

结局指标

主要结局

Correlation Between Echocardiographic Diastolic Parameters and Inflammatory Biomarkers

时间窗: 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.

次要结局

  • Mean E/A Ratio(Baseline (at ICU admission))
  • Mean E/e' Ratio(Baseline (at ICU admission))
  • Mean Left Atrial Volume Index (LAVI)(Baseline (at ICU admission))
  • Mean C-Reactive Protein (CRP) Level(Baseline (at ICU admission))
  • Mean Neutrophil-to-Lymphocyte Ratio (NLR)(Baseline (at ICU admission))
  • Mean SLEDAI-2K Score(Baseline (at ICU admission))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Mohamed Abdelmohsen Abdelaal

Resident Physician, Department of Internal Medicine

Assiut University

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