Cardiac and Laboratory Findings in Patients With Systemic Lupus Erythematosus

NCT03179046 | Completed

• 1 other identifier: 17200078
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to investigate the association of the clinical and laboratory parameters or data with the cardiac structural and functional abnormalities in systemic lupus erythematosus(SLE). Patients with at least four ACR classification criteria for SLE and stable clinical condition (no need for immunosuppressive therapy intensification, i.e. current immunosuppressive drug dose increase or introduction of an additional immunosuppressive drug within last 3 months) will be included in the study. Study procedures will include clinical evaluation, lab tests including blood counts, liver and kidney functions and antibodies levels such as ANA, antiphospholipid antibodies, anti-ds DNA as well as inflammatory markers such as sedimentation rates. Also evaluation of cardiac status by cardiologist examination echocardiography and gadolinium enhanced cardiac MRI. Next, correlation between cardiac abnormalities and laboratory changes will be statistically analyzed.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (3)

• Correlation between echocardiographic parameters and the presence of autoantibodies as well as the concentration of CRP and complement C3 and C4 components.

  Correlation between echocardiographic parameters (left ventricle diastolic and systolic dimensions, its ejection fraction, thickness of the walls in diastole, left atrium diameter, right ventricle diastolic diameter, ascending aorta diameter, mitral and tricuspid inflow velocity, valvular pressure gradients, regurgitation assessment , thickness of pericardium and the presence of pericardial effusion) and the presence of autoantibodies as well as the concentration of CRP and complement C3 and C4 components.

  1year

• The presence of subclinical myocarditis, assessment of coronary blood flow, left and right ventricle as shown by cardiac MRI and its correlation with autoantibodies.

  The presence of subclinical myocarditis, assessment of coronary blood flow, left and right ventricle (including ventricular size, thickness, wall motion, and ejection fraction) as shown by cardiac MRI(Multiple consecutive MR image sections will be obtained from the apex to the base of the heart. T2 and T1 mapping will be performed. T1-weighted inversion recovery scout images will be acquired 15 min after injection of 0.2 mmol/kg of gadolinium based contrast agent. The functional and volumetric analysis will be performed to quantify ventricular volumes and functions. ) and its correlation with autoantibodies.

  1 year

• Correlation between cardiac abnormalities (evaluated with Echocardiography and cardiac MRI) and disease activity evaluated with SELDAI score.

  Correlation between cardiac abnormalities(evaluated with Echocardiography and cardiac MRI) and disease activity evaluated with SELDAI score.

  1 year

Interventions

Laboratory tests and cardiac imaging DIAGNOSTIC_TEST

Laboratory tests (blood count, liver and kidney functions, antibodies, acute phase reactants), Echocardiography and gadolinium enhanced cardiac MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patients have at least four ACR classification criteria for SLE. * Stable clinical condition (no need for immunosuppressive therapy intensification, i.e. current immunosuppressive drug dose increase or introduction of an additional immunosuppressive drug within last 3 months).

You may qualify if:

• Patients have at least four ACR classification criteria for SLE.
• Stable clinical condition (no need for immunosuppressive therapy intensification, i.e. current immunosuppressive drug dose increase or introduction of an additional immunosuppressive drug within last 3 months).

You may not qualify if:

• Patients less than 18 years old
• Clinical symptoms of heart failure.
• Renal failure (creatinine clearance \< 30 ml/ min).
• Respiratory failure.
• Pregnancy.
• Patients with contraindications for MRI e.g. patients with aneurysm clips or cardiac pacemakers and patients who are sensitive to gadolinium dye.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Facultu of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: June 4, 2017
• First Posted: June 7, 2017
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)