SclerodermaBOSS-PHNCT03459716
Endothelial Biomarkers of Systemic Sclerosis-associated Pulmonary Hypertension
An observational study of Scleroderma and Pulmonary Hypertension, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Pulmonary Hypertension
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 1 Dec 2021
- 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
- Adult, Older adult
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.
Who may be able to join
- 1. Age >18 years 2. Meet American College of Rheumatology criteria for SSc
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University Medical Center-New Orleans
New Orleans, Louisiana, 70112
Matthew R Lammi, MD, MSCR, 504-568-4634, mlammi@lsuhsc.edu
About this study
Official title: Novel Screening Strategy for Systemic Sclerosis-associated Pulmonary Hypertension Incorporating Endothelial Biomarkers
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
- Being tested
- No intervention
- Keywords
- Biomarkers, Endothelial microparticles
- Medical subject headings
- Scleroderma, Diffuse, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Systemic sclerosis patients w/ PH | Pulmonary hypertension will be defined as a mean pulmonary artery pressure≥25mmHg on right heart catheterization Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline
Secondary 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
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Jun 2018
- Primary completion31 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- Scleroderma Foundation, Tulane University Health Sciences Center, University Medical Center New Orleans
- Responsible party
- Principal investigator, Matthew Lammi, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Matthew R Lammi, MD, MSCR, Principal investigator, LSU Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459716
- Sponsor's protocol ID
- IRB 10033SM
- Acronym
- BOSS-PH
- Status last verified
- Sep 2021
- First submitted
- 1 Mar 2018
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Screening Strategy for Systemic Sclerosis-associated Pulmonary Hypertension Incorporating Endothelial Biomarkers
- ClinicalTrials.gov ID
- NCT03459716
- Acronym / sponsor ID
- BOSS-PH / IRB 10033SM
- Conditions
- Scleroderma, Pulmonary Hypertension
- Keywords
- Biomarkers, Endothelial microparticles
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- Scleroderma Foundation, Tulane University Health Sciences Center, University Medical Center New Orleans
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 9 Mar 2018 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic sclerosis patients w/ PH | – | Other: No interventionPulmonary hypertension will be defined as a mean pulmonary artery pressure≥25mmHg on right heart catheterization |
| Systemic sclerosis patients w/o PH | – | Other: No interventionPulmonary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1. Age >18 years 2. Meet American College of Rheumatology criteria for SSc
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| No interventionNo intervention | Other | Systemic sclerosis patients w/ PH, Systemic sclerosis patients w/o PH |
Primary outcome
Composite pulmonary hypertension detection score
Time frame: At baseline
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
1 secondary outcome
Composite pulmonary hypertension detection score
Time frame: At 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Matthew R Lammi, MD, MSCR principal investigator
LSU Health Sciences Center
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 Scleroderma and Pulmonary Hypertension, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Sep 2021. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew R Lammi, MD, MSCR (504-568-4634, mlammi@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite pulmonary hypertension detection score (time frame: At baseline). 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 10 Sep 2021.