Endothelial Biomarkers of Systemic Sclerosis-associated Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

— BOSS-PH  

Official title:

Novel Screening Strategy for Systemic Sclerosis-associated Pulmonary Hypertension Incorporating Endothelial Biomarkers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03459716
• Other study ID #: IRB 10033SM
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: September 2021
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: Matthew R Lammi, MD, MSCR
• Phone: 504-568-4634
• Email: mlammi[@]lsuhsc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 1, 2021
• Est. primary completion date: October 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Chronic kidney disease (estimated creatinine clearance <50mL/min)

2. Uncontrolled hypertension (diastolic blood pressure>120mmHg)

3. Acute coronary syndrome within the past 6 months

4. Chronic obstructive pulmonary disease

5. Diabetes mellitus

6. Hemolytic anemia

7. Active tobacco abuse

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
United States	University Medical Center-New Orleans	New Orleans	Louisiana

Sponsors (4)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans	Scleroderma Foundation, Tulane University Health Sciences Center, University Medical Center-New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 12 months