Systemic Lupus ErythematosusNCT03179046
Cardiac and Laboratory Findings in Patients With Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus, run by Assiut University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Laboratory tests and cardiac imaging
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Heart Structure and Function Abnormalities With Laboratory Findings in Patients With Systemic Lupus Erythematosus
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.
Read the detailed description
- Subject recruitment and obtaining consent Study subjects (SLE patients) will be recruited from patients attending outpatient clinic and inpatients of the Rheumatology and Rehabilitation Department, Faculty of Medicine, Assiut University. Written informed consent form will be obtained from each patient.
- Baseline evaluation:
- All SLE patients selected for the study will fulfill the ACR criteria for the diagnosis of SLE .
- Thorough clinical history and examination will be performed to all SLE patients. Pulmonary function (PFTs) test will be performed to exclude respiratory failure.
- Urine pregnancy test to exclude pregnancy will be performed to all SLE females' patients of the childbearing period in the study group.
- Laboratory tests: the following tests will be performed to all study population:
- Complete blood count (CBC),
- Liver and kidney functions and measurement of protein in urine collected over 24 hours,
- Levels of Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP).
- Antinuclear antibodies (ANA) and their titer will be assessed by indirect immunofluorescence,
- Complement system C3 and C4 factors will be measured to determine disease activity,
- Serum levels of anticardiolipin (aCL) and lupus anticoagulant antibodies will be measured using ELISA.
- Disease activity will be assessed by using SELDAI score [11].
- Cardiac evaluation
- Echocardiography will be performed to evaluate structural and functional outcome measures.
- 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Laboratory tests and cardiac imaging
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory tests and cardiac imagingDiagnostic test
Laboratory tests (blood count, liver and kidney functions, antibodies, acute phase reactants), Echocardiography and gadolinium enhanced cardiac MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Apr 2018
- Primary completion1 Apr 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Sayed Ibrahim Abdelrahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179046
- Sponsor's protocol ID
- 17200078
- Status last verified
- Jul 2019
- First submitted
- 4 Jun 2017
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Heart Structure and Function Abnormalities With Laboratory Findings in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT03179046
- Acronym / sponsor ID
- 17200078
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Subject recruitment and obtaining consent Study subjects (SLE patients) will be recruited from patients attending outpatient clinic and inpatients of the Rheumatology and Rehabilitation Department, Faculty of Medicine, Assiut University. Written informed consent form will be obtained from each patient.
- Baseline evaluation:
- All SLE patients selected for the study will fulfill the ACR criteria for the diagnosis of SLE .
- Thorough clinical history and examination will be performed to all SLE patients. Pulmonary function (PFTs) test will be performed to exclude respiratory failure.
- Urine pregnancy test to exclude pregnancy will be performed to all SLE females' patients of the childbearing period in the study group.
- Laboratory tests: the following tests will be performed to all study population:
- Complete blood count (CBC),
- Liver and kidney functions and measurement of protein in urine collected over 24 hours,
- Levels of Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP).
- Antinuclear antibodies (ANA) and their titer will be assessed by indirect immunofluorescence,
- Complement system C3 and C4 factors will be measured to determine disease activity,
- Serum levels of anticardiolipin (aCL) and lupus anticoagulant antibodies will be measured using ELISA.
- Disease activity will be assessed by using SELDAI score [11].
- Cardiac evaluation
- Echocardiography will be performed to evaluate structural and functional outcome measures.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- Patients less than 18 years old
- Clinical symptoms of heart failure.
- Renal failure (creatinine clearance < 30 ml/ min).
- Respiratory failure.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory tests and cardiac imagingLaboratory tests (blood count, liver and kidney functions, antibodies, acute phase reactants), Echocardiography and gadolinium enhanced cardiac MRI | Diagnostic test | – |
Primary outcome
Correlation between echocardiographic parameters and the presence of autoantibodies as well as the concentration of CRP and complement C3 and C4 components.
Time frame: 1year
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.
The presence of subclinical myocarditis, assessment of coronary blood flow, left and right ventricle as shown by cardiac MRI and its correlation with autoantibodies.
Time frame: 1 year
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.
Correlation between cardiac abnormalities (evaluated with Echocardiography and cardiac MRI) and disease activity evaluated with SELDAI score.
Time frame: 1 year
Correlation between cardiac abnormalities(evaluated with Echocardiography and cardiac MRI) and disease activity evaluated with SELDAI score.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between echocardiographic parameters and the presence of autoantibodies as well as the concentration of CRP and complement C3 and C4 components. (time frame: 1year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.