Pulmonary Hypertension Screening for Rheumatology Patients (SOPHIE)

NCT03446339 | Unknown DMC

• 1 other identifier: PH_Screening_1.4.2017 ver.1
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary arterial hypertension (PAH) is a serious and often fatal complication of connective tissue diseases including systemic sclerosis and systemic lupus erythematosus. It has been reported primarily from European series that the prevalence of PAH in patients with connective tissue diseases particularly systemic sclerosis is as high as 15-20%. However, given the paucity of medical literature in the area from Chinese population, the prevalence of PAH amongst Chinese patients with these conditions is largely unknown. Even worse, PAH is often undiagnosed amongst patients with connective tissue diseases due to the lack of awareness and/or access to echocardiography, which is a non-invasive first-line screening tool for PAH. As a result, most patients at diagnosis of PAH are at a relatively late stage, rendering pharmacological treatment less effective. Here, the investigators propose a territory-wide pulmonary hypertension screening for patients with connective tissue disease in order to (1) detect pulmonary hypertension amongst patients with connective tissue disease through systematic screening, and (2) understand the prevalence of pulmonary hypertension in Chinese patients with connective tissue diseases.

Conditions

Connective Tissue Diseases; Systemic Sclerosis; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Prevalence of asymptomatic pulmonary hypertension in Chinese patients with connective tissue diseases

  Proportion of patients diagnosed to have pulmonary hypertension

  36 months

Secondary Outcomes (2)

• Clinical predictor of Echocardiography for pulmonary hypertension in Chinese patients with connective tissue diseases

  36 months

• Clinical predictor of BNP assay for pulmonary hypertension in Chinese patients with connective tissue diseases

  36 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1,800 rheumatology patients with connective tissue diseases from public hospitals within Hospital Authority of Hong Kong

You may qualify if:

• Patientw with either (1) systemic lupus erythematosus, (2) systemic sclerosis, or (3) other connective tissue diseases at risk of pulmonary hypertension
• Voluntarily agrees to participate by providing written informed consent
• Age ≥ 18 at enrolment

You may not qualify if:

• \- Refuse to participate the study

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Connective Tissue Diseases; Scleroderma, Systemic; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Skin Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David Chung-Wah Siu, Professor

  The Universtiy of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Chung-Wah Siu, Professor

CONTACT

+852-22554694; cwdsiu@hku.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 26, 2018
• Study Start: August 3, 2017
• Primary Completion: August 31, 2023
• Study Completion: December 1, 2023
• Last Updated: August 3, 2021

Record last verified: 2021-08

Locations

CN (1)