Endothelial Biomarkers of Systemic Sclerosis-associated Pulmonary Hypertension

NCT03459716 | Unknown

• 1 other identifier: IRB 10033SM
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic sclerosis (SSc, AKA scleroderma) is an autoimmune condition characterized by endothelial damage and progressive fibrosis of the skin and internal organs. One of the leading causes of morbidity and mortality in patients with SSc is pulmonary hypertension (PH), which is estimated to occur in up to 31% of high risk SSc patients. Early detection of patients with SSc-PH may lead to improved outcomes and although there have been concerted efforts to accurately screen for SSc-PH, these patients continue to present with advanced disease and suffer from poor survival. Therefore, better methods to screen for patients with PH and, perhaps more importantly, to screen for those at risk for PH development are desperately needed. Since PH and SSc are disorders originating from the endothelium, biomarkers that reflect endothelial damage are very promising tools to identify early disease. Such potential biomarkers include endothelial microparticles, asymmetric dimethylarginine (ADMA), pentraxin-3, and soluble endoglin. No previous study has used a combination of these biomarkers to detect the presence of PH in patients with SSc, or studied the novel concept of exercise-induced changes in biomarker levels. The investigators will collect the above listed endothelial biomarkers before and after exercise, and combine these levels with exercise echocardiogram findings, and routine clinical information to derive a composite detection score for the early identification of systemic sclerosis-associated PH.

Conditions

Scleroderma; Pulmonary Hypertension

Keywords

Biomarkers; Endothelial microparticles

Outcome Measures

Primary Outcomes (1)

• Composite pulmonary hypertension detection score

  A score will be derived by incorporating biomarkers, exercise echo results, pulmonary function tests, autoantibody status, 6-minute walk results, etc. into a linear regression model

  At baseline

Secondary Outcomes (1)

• Composite pulmonary hypertension detection score

  At 12 months

Study Arms (2)

Systemic sclerosis patients w/ PH

Pulmonary hypertension will be defined as a mean pulmonary artery pressure≥25mmHg on right heart catheterization

Other: No intervention

Systemic sclerosis patients w/o PH

Pulmonary hypertension will be excluded based on all of the following echocardiogram features: estimated systolic pulmonary artery pressure\<35mmHg and absence of right atrial or right ventricular (RV) enlargement and lack of qualitative RV dysfunction. If a subject has any of these echo features, they will be referred for right heart catheterization (RHC) and included in the appropriate group based on their RHC results.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Systemic sclerosis patients w/ PH; Systemic sclerosis patients w/o PH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 26 patients with systemic sclerosis-associated pulmonary hypertension and 26 patients with systemic sclerosis but no diagnosis of current pulmonary hypertension.

You may qualify if:

• \. Age \>18 years 2. Meet American College of Rheumatology criteria for SSc

You may not qualify if:

• 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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• Scleroderma Foundation: collaborator
• Tulane University Health Sciences Center: collaborator
• University Medical Center-New Orleans: collaborator

Study Sites (1)

University Medical Center-New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

MeSH Terms

Conditions

Scleroderma, Diffuse; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Matthew R Lammi, MD, MSCR

  LSU Health Sciences Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew R Lammi, MD, MSCR

CONTACT

504-568-4634; mlammi@lsuhsc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 9, 2018
• Study Start: June 1, 2018
• Primary Completion: October 31, 2021
• Study Completion: December 1, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

US (1)