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Endothelial Microparticles in Systemic Sclerosis Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT02331225
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : December 16, 2016
Sponsor:
Collaborator:
University of South Alabama
Information provided by (Responsible Party):
Matthew Lammi, Louisiana State University Health Sciences Center in New Orleans

Brief Summary:
Systemic sclerosis (SSc, also known as scleroderma) is a disease characterized by fibrosis of the skin and organs, inflammation, and an abnormal endothelial cell lining inside of vessels. A common and deadly complication of SSc is pulmonary hypertension (PH), which is an abnormal elevation in the blood pressure within the lung blood vessels. Early identification and treatment of PH is important in SSc, and no clinical factors can predict which patients will develop PH with acceptable accuracy. A potential marker of PH in SSc is the presence of increased amounts of endothelial microparticles (EMPs), which are substances circulating in the blood that were released from damaged vessel wall endothelial lining. A main goal of this study is to investigate if there is a difference in EMP levels between SSc patients with and without PH. The investigators will also use human endothelial cells in a lab environment to test whether these EMPs isolated from SSc patients are actually causing damage to the vessel lining. Lastly, the investigators will investigate the potential benefit of a medication used after transplant, mycophenolate mofetil (MMF). This will be done by causing damage to isolated human endothelial cells and treating them with MMF. The main goal of this portion of our study is to see if EMP levels are reduced when cells are treated with MMF. Overall, the investigators anticipate the following outcomes of this study: 1) use EMP levels to differentiation patients with SSc who have PH from those without PH, 2) use EMPs to understand how endothelial damage occurs in SSc, and 3) use EMPs to help us develop new treatments for patients with vascular diseases.

Condition or disease Intervention/treatment
Systemic Sclerosis Pulmonary Hypertension Scleroderma Other: No intervention given

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Endothelial Mircroparticles as a Biomarker of Pulmonary Hypertension in Systemic Sclerosis
Study Start Date : December 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : October 2016


Group/Cohort Intervention/treatment
Systemic sclerosis, no pulmonary hypertension
This group will be systemic sclerosis patients without pulmonary hypertension
Other: No intervention given
There is no intervention for this study

Systemic sclerosis/pulmonary hypertension
This group will be systemic sclerosis patients with pulmonary hypertension
Other: No intervention given
There is no intervention for this study

Healthy controls
These will be healthy age- and sex-matched controls
Other: No intervention given
There is no intervention for this study




Primary Outcome Measures :
  1. Plasma VE-cadherin + endothelial microparticle levels [ Time Frame: Baseline ]
    endothelial microparticles are expressed as microparticles per microliter of plasma. This is a cross-sectional analysis, so the measurements will be performed once, on study visit 1


Secondary Outcome Measures :
  1. Plasma PECAM+ endothelial microparticles [ Time Frame: Baseline ]
    endothelial microparticles are expressed as microparticles per microliter of plasma. This is a cross-sectional analysis, so the measurements will be performed once, on study visit 1

  2. Plasma E-selectin + endothelial microparticles [ Time Frame: Baseline ]
    endothelial microparticles are expressed as microparticles per microliter of plasma. This is a cross-sectional analysis, so the measurements will be performed once, on study visit 1


Biospecimen Retention:   Samples Without DNA
Blood will be retained.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
There will be 3 groups: systemic sclerosis subjects with pulmonary hypertension, systemic sclerosis subjects without pulmonary hypertension, and healthy age- and sex-matched controls.
Criteria

For systemic sclerosis subjects:

Inclusion Criteria:

  • Age >18 years
  • Meet American College of Rheumatology criteria for systemic sclerosis

Exclusion Criteria:

  • Chronic kidney disease (estimated creatinine clearance <50mL/min)
  • Uncontrolled hypertension (diastolic blood pressure>120mmHg)
  • Acute coronary syndrome within the past 6 months
  • Chronic obstructive pulmonary disease
  • Diabetes mellitus
  • Hemolytic anemia
  • Active tobacco abuse

For healthy control subjects:

Inclusion Criteria:

  • Age>18 years
  • Age- and sex-matched to SSc patients

Exclusion criteria:

  • Coronary artery disease
  • Uncontrolled hypertension (diastolic blood pressure>120mmHg)
  • Chronic obstructive pulmonary disease
  • Chronic kidney disease
  • Diabetes mellitus
  • Hemolytic anemia
  • Active tobacco abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331225


Locations
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United States, Louisiana
LSU Health Sciences Center
New Orleans, Louisiana, United States, 70125
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
University of South Alabama
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthew Lammi, Assistant Professor of Medicine, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT02331225    
Other Study ID Numbers: 8772
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases