Diastolic Dysfunction and Inflammatory Biomarkers in Lupus Nephritis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
90 Participants
are grouped into 3 trial groupsGroup A: Control Group
Group B: SLE without Lupus Nephritis
Group C: SLE with Lupus Nephritis
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
Mean E/A Ratio
Mean early-to-late diastolic filling velocity ratio (E/A) measured by transthoracic echocardiography.
Time frame
Baseline (at ICU admission)2
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)3
Mean Left Atrial Volume Index (LAVI)
Mean left atrial volume index in mL/m² measured by transthoracic echocardiography.
Time frame
Baseline (at ICU admission)4
Mean C-Reactive Protein (CRP) Level
Mean serum C-reactive protein level in mg/L measured by immunoturbidimetry.
Time frame
Baseline (at ICU admission)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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