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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01031797
Other study ID # 86-1256
Secondary ID
Status Completed
Phase N/A
First received December 12, 2009
Last updated December 12, 2009
Start date January 2008
Est. completion date March 2009

Study information

Verified date July 2007
Source Shiraz University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran:NIH
Study type Observational

Clinical Trial Summary

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.


Description:

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).


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Iran, Islamic Republic of Shiraz University of Medical Sciences Shiraz Fars

Sponsors (1)

Lead Sponsor Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary QT dispersion No
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