NCT03889509

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

March 22, 2019

Last Update Submit

August 17, 2022

Conditions

Keywords

systemic sclerosissclerodermapulmonary hypertensionpulmonary arterial hypertension

Outcome Measures

Primary Outcomes (2)

  • Prevalence of Pulmonary arterial hypertension in scleroderma

    to determine the prevalence associated with pulmonary arterial hypertension in scleroderma

    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

    2 years from study start date

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study reflects a search strategy of available literature on pulmonary arterial hypertension in scleroderma.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology Clinic, St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Pulmonary Arterial HypertensionScleroderma, SystemicScleroderma, DiffuseHypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Janet E Pope, MD MPH

    St. Joseph's healthcare London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 22, 2019

First Posted

March 26, 2019

Study Start

March 1, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2021

Last Updated

August 19, 2022

Record last verified: 2022-08

Locations