Diastolic Dysfunction and Inflammatory Biomarkers in Lupus Nephritis

September 23, 2026 updated by: Alaa Mohamed Abdelmohsen Abdelaal, Assiut University

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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: CASE_CONTROL
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Echocardiographic Diastolic Parameters and Inflammatory Biomarkers
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean E/A Ratio
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: Baseline (at ICU admission)

Mean neutrophil-to-lymphocyte ratio calculated from complete blood count.

Baseline (at ICU admission)
Mean SLEDAI-2K Score
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: sohair m kasim, prof, Critical Care Unit Department of Internal Medicine, Assiut University Hospital, Assiut, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 20, 2026

Primary Completion (Estimated)

September 20, 2027

Study Completion (Estimated)

March 10, 2028

Study Registration Dates

First Submitted

September 18, 2026

First Submitted That Met QC Criteria

September 18, 2026

First Posted (Actual)

September 23, 2026

Study Record Updates

Last Update Posted (Actual)

September 24, 2026

Last Update Submitted That Met QC Criteria

September 23, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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