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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03889509
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lawson Health Research Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janet E Pope, MD MPH
Principal Investigator Affiliation St. Joseph's healthcare London
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension, Systemic Sclerosis
Additional Details

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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International Sites

London, Ontario, Canada

Status

Address

Rheumatology Clinic, St. Joseph's Health Care

London, Ontario, N6A 4V2

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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