- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
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.
Panoramica dello studio
Stato
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Alaa M Abdelaal, Resident
- Numero di telefono: 01156604132
- Email: Alaa.18313526@med.aun.edu.eg
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: CASE_CONTROL
- Prospettive temporali: CROSS_SECTIONAL
Coorti e interventi
Gruppo / Coorte |
|---|
|
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Correlation Between Echocardiographic Diastolic Parameters and Inflammatory Biomarkers
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean E/A Ratio
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Baseline (at ICU admission)
|
Mean neutrophil-to-lymphocyte ratio calculated from complete blood count. |
Baseline (at ICU admission)
|
|
Mean SLEDAI-2K Score
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: sohair m kasim, prof, Critical Care Unit Department of Internal Medicine, Assiut University Hospital, Assiut, Egypt
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattia cardiovascolare
- Processi patologici
- Malattie urogenitali maschili
- Malattie renali
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie cardiache
- Attributi della malattia
- Malattie del tessuto connettivo
- Malattie autoimmuni
- Malattie del sistema immunitario
- Glomerulonefrite
- Nefrite
- Arresto cardiaco
- Condizioni patologiche, segni e sintomi
- Malattie della pelle e del tessuto connettivo
- Lupus Eritematoso, Sistemico
- Malattia critica
- Nefrite da lupus
- Insufficienza cardiaca, diastolica
Altri numeri di identificazione dello studio
- LN-DiastolicDysfunction-2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .