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A Systematic Review of Factors Associated With Pulmonary Arterial Hypertension in Systemic Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03889509
Recruitment Status : Active, not recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Janet Pope, Lawson Health Research Institute

Brief Summary:
This protocol is of a systematic review for risk factors of pulmonary arterial hypertension in systemic sclerosis.

Condition or disease
Pulmonary Arterial Hypertension 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 )

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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: A Systematic Review of Factors Associated With Pulmonary Arterial Hypertension in Systemic Sclerosis
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2021





Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study reflects a search strategy of available literature on pulmonary arterial hypertension in scleroderma.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT03889509


Locations
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Canada, Ontario
Rheumatology Clinic, St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Janet E Pope, MD MPH St. Joseph's healthcare London
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Responsible Party: Janet Pope, Professor of Medicine, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03889509    
Other Study ID Numbers: YJJEP0001
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janet Pope, Lawson Health Research Institute:
systemic sclerosis
scleroderma
pulmonary hypertension
pulmonary arterial hypertension
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases