- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Alaa M Abdelaal, Resident
- 전화번호: 01156604132
- 이메일: Alaa.18313526@med.aun.edu.eg
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_CONTROL
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Correlation Between Echocardiographic Diastolic Parameters and Inflammatory Biomarkers
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean E/A Ratio
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: Baseline (at ICU admission)
|
Mean neutrophil-to-lymphocyte ratio calculated from complete blood count. |
Baseline (at ICU admission)
|
|
Mean SLEDAI-2K Score
기간: 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)
|
공동 작업자 및 조사자
수사관
- 연구 의자: sohair m kasim, prof, Critical Care Unit Department of Internal Medicine, Assiut University Hospital, Assiut, Egypt
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- LN-DiastolicDysfunction-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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