Pulmonary Arterial HypertensionNCT03889509
A Systematic Review of Factors Associated With Pulmonary Arterial Hypertension in Systemic Sclerosis
An observational study of Pulmonary Arterial Hypertension and Systemic Sclerosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This protocol is of a systematic review for risk factors of pulmonary arterial hypertension in systemic sclerosis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension, Systemic Sclerosis
- How many people
- 63 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2018to 1 Mar 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study reflects a search strategy of available literature on pulmonary arterial hypertension in scleroderma.
Who may be able to join
- Studies were included they were (1) in patients with SSc; and if they (2) determined PAH with right heart catheterization; (3) involved a comparison of SSc patients with and without PAH; and (4) had sample size larger than 20.
Who cannot join
- Studies were excluded if they were review articles, and if the study was written in languages other than English. When the same patients were used in more than one analysis, the most recent or largest sample-size study was included.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Rheumatology Clinic, St. Joseph's Health Care
London, Ontario, N6A 4V2
About this study
This protocol is of a systematic review for risk factors of pulmonary arterial hypertension in systemic sclerosis.
Read the detailed description
A systematic review was conducted to determine the risk/associated factors for pulmonary arterial hypertension in systemic sclerosis, including clinical/disease characteristics, antibody status, test results and biomarkers. The frequency of publications featuring a risk/association were reported. The following databases were searched: Medline, EMBASE, the Cochrane Library, Web of Science, and SCOPUS.
The following search terms were used:
( essential pulmonary hypertension or familial primary pulmonary hypertension or hypertension, pulmonary or hypertension,lung or hypertensive pulmonary vascular disease or idiopathic pulmonary arterial hypertension or lung arterial hypertension or lung artery hypertension or lung hypertension or primary pulmonary hypertension or pulmonary arterial hypertension or pulmonary artery hypertension or pulmonary fixed hypertension or pulmonary hypertensive disease or pulmonary hypertensive diseases or pulmonary hypertensive disorder or pulmonary hypertensive disorders )
AND
( generalised scleroderma or generalized scleroderma or progressive scleroderma or progressive sclerodermia or progressive sclerosis,systemic or progressive systemic sclerosis or scleroderma, generalised or scleroderma, generalized or scleroderma, progressive or scleroderma, systemic or sclerosis,progressive systemic or sclerosis,systemic or sclerosis,systemic progressive or systemic progressive sclerosis or systemic scleroderma or systemic sclerosis,progressive or
scleroderma, limited or limited scleroderma or limited cutaneous scleroderma or
diffuse scleroderma or progressive diffuse scleroderma or scleroderma, diffuse )
AND
( prevalence or prevalence study or relative risk or risk factors )
- Keywords
- systemic sclerosis, scleroderma, pulmonary hypertension, pulmonary arterial hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension, Scleroderma, Systemic, Scleroderma, Diffuse, Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Pulmonary arterial hypertension in scleroderma
to determine the prevalence associated with pulmonary arterial hypertension in scleroderma
Measured: 2 years from study start date
Risk factors for pulmonary arterial hypertension in scleroderma
to determine the risk factors associated with pulmonary arterial hypertension in scleroderma
Measured: 2 years from study start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Mar 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Pope, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Janet E Pope, MD MPH, Principal investigator, St. Joseph's healthcare London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889509
- Sponsor's protocol ID
- YJJEP0001
- Status last verified
- Aug 2022
- First submitted
- 22 Mar 2019
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systematic Review of Factors Associated With Pulmonary Arterial Hypertension in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT03889509
- Acronym / sponsor ID
- YJJEP0001
- Keywords
- systemic sclerosis, scleroderma, pulmonary hypertension, pulmonary arterial hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 26 Mar 2019 (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 protocol is of a systematic review for risk factors of pulmonary arterial hypertension in systemic sclerosis.
Detailed description
A systematic review was conducted to determine the risk/associated factors for pulmonary arterial hypertension in systemic sclerosis, including clinical/disease characteristics, antibody status, test results and biomarkers. The frequency of publications featuring a risk/association were reported. The following databases were searched: Medline, EMBASE, the Cochrane Library, Web of Science, and SCOPUS.
The following search terms were used:
( essential pulmonary hypertension or familial primary pulmonary hypertension or hypertension, pulmonary or hypertension,lung or hypertensive pulmonary vascular disease or idiopathic pulmonary arterial hypertension or lung arterial hypertension or lung artery hypertension or lung hypertension or primary pulmonary hypertension or pulmonary arterial hypertension or pulmonary artery hypertension or pulmonary fixed hypertension or pulmonary hypertensive disease or pulmonary hypertensive diseases or pulmonary hypertensive disorder or pulmonary hypertensive disorders )
AND
( generalised scleroderma or generalized scleroderma or progressive scleroderma or progressive sclerodermia or progressive sclerosis,systemic or progressive systemic sclerosis or scleroderma, generalised or scleroderma, generalized or scleroderma, progressive or scleroderma, systemic or sclerosis,progressive systemic or sclerosis,systemic or sclerosis,systemic progressive or systemic progressive sclerosis or systemic scleroderma or systemic sclerosis,progressive or
scleroderma, limited or limited scleroderma or limited cutaneous scleroderma or
diffuse scleroderma or progressive diffuse scleroderma or scleroderma, diffuse )
AND
( prevalence or prevalence study or relative risk or risk factors )
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study reflects a search strategy of available literature on pulmonary arterial hypertension in scleroderma.
Key inclusion criteria (1 listed)
- Studies were included they were (1) in patients with SSc; and if they (2) determined PAH with right heart catheterization; (3) involved a comparison of SSc patients with and without PAH; and (4) had sample size larger than 20.
Key exclusion criteria (1 listed)
- Studies were excluded if they were review articles, and if the study was written in languages other than English. When the same patients were used in more than one analysis, the most recent or largest sample-size study was included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Pulmonary arterial hypertension in scleroderma
Time frame: 2 years from study start date
to determine the prevalence associated with pulmonary arterial hypertension in scleroderma
Risk factors for pulmonary arterial hypertension in scleroderma
Time frame: 2 years from study start date
to determine the risk factors associated with pulmonary arterial hypertension in scleroderma
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 19 Aug 2022.
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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.
Janet E Pope, MD MPH principal investigator
St. Joseph's healthcare London
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 Pulmonary Arterial Hypertension and Systemic Sclerosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 1 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 19 Aug 2022. 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 Canada. 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?
Prevalence of Pulmonary arterial hypertension in scleroderma (time frame: 2 years from study start date). The study lists 2 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 19 Aug 2022.