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临床试验/NCT01031797
NCT01031797已完成不适用

QT Dispersion in Patients With Systemic Lupus Erythematosus: the Impact of Disease Activity

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
1
主要终点
QT dispersion

研究概览

简要总结

QT dispersion can be a useful, simple noninvasive method for the early detection of cardiac involvement in SLE patients with active disease. The investigators therefore recommend cardiovascular evaluation for every SLE patient with an SLEDAI higher than 10.

详细描述

Objective

Patients with systemic lupus erythematosus (SLE) have increased cardiovascular morbidity and mortality. Although autopsy studies have documented that the heart is affected in most SLE patients, clinical manifestations occur in less than 10%. QT dispersion is a new parameter that can be used to assess homogeneity of cardiac repolarization and autonomic function. We compared the increase in QT dispersion in SLE patients with high disease activity and mild or moderate disease activity.

Methods: One hundred twenty-four patients with SLE were enrolled in the study. Complete history and physical exam, ECG, echocardiography, exercise test and SLE disease activity index (SLEDAI) were recorded. Twenty patients were excluded on the basis of our exclusion criteria. The patients were divided to two groups based on SLEDAI: 54 in the high-score group (SLEDAI >10) and 50 in the low-score group (SLEDAI <10).

研究设计

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

入排标准

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

入选标准

  • no administration of drugs that would potentially influence QT duration except hydroxychloroquine
  • no history of ischemic heart disease, congestive heart failure, atrial fibrillation, bundle branch block or abnormal serum electrolytes
  • normal resting ECG and a good-quality ECG recording to measure the QT interval.

排除标准

  • moderate or severe valve disease
  • atrial fibrillation and other ECG abnormalities
  • systolic left ventricular dysfunction (ejection fraction <50% or left ventricular end diastolic dimension >5.5 mm
  • unreliable identification of the end of the T wave in the ECG and
  • known presence of cardiac disease including hypertension, diabetes or coronary artery disease.

结局指标

主要结局

QT dispersion

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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