Pulmonary Hypertension Screening for Rheumatology Patients (SOPHIE) (PAH)

Territory-Wide Pulmonary Hypertension Screening Amongst Patients With Connective Tissue Diseases: A Prospective Screening Study

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.

Study Overview

• Status: Recruiting
• Conditions: Connective Tissue Diseases; Systemic Lupus Erythematosus; Systemic Sclerosis

Detailed Description

Objectives:

1. To detect pulmonary hypertension amongst patients with connective tissue diseases through systematic screening
2. To understand the prevalence of pulmonary hypertension in Chinese patients with connective tissue diseases

Study design:

The study is a territory-wide pulmonary hypertension screening project. Patients fulfilling the inclusion and exclusion criteria will undergo screen echocardiography as baseline to detect subclinical pulmonary hypertension.

Screening procedure:

Participants will undergo usual clinical assessment by the rheumatology teams of the parent hospitals including standard 12-lead ECG and 6-minute hall walk distance. then they will be referred to the Division of Cardiology, the Department of Medicine, the University of Hong Kong for (1) Echocardiography and (2) BNP (or pro-NT BNP) assay. The echocardiography will be performed based on the European Society of Cardiology (ESC)/European Respiratory Society (ERS) Guidelines. The echocardiographic probability of pulmonary hypertension will be determined (low, intermediate, and high).

Statistical analysis and power calculation:

There are no studies on which to calculate a power equation, because there are no previous reports on the prevalence of pulmonary hypertension in Chinese rheumatological patients. The sample size is based on our local prevalence of the rheumatological diseases.

Continuous variables will be expressed in mean ± SD. Statistical comparisons were performed using Student's t test or Fisher's exact test, as appropriate. The outcomes would be analyzed.

• Study Type: Observational
• Enrollment (Anticipated): 1800

Contacts and Locations

• Study Contact: Name: David Chung-Wah Siu, Professor; Phone Number: +852-22554694; Email: cwdsiu@hku.hk

Study Locations

• China
  • Hong Kong, China
    • Recruiting
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

- Refuse to participate the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of asymptomatic pulmonary hypertension in Chinese patients with connective tissue diseases	Proportion of patients diagnosed to have pulmonary hypertension	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical predictor of Echocardiography for pulmonary hypertension in Chinese patients with connective tissue diseases	Cardiac functional and structural data for pulmonary hypertension detection	36 months
Clinical predictor of BNP assay for pulmonary hypertension in Chinese patients with connective tissue diseases	Cardiac marker for cardiac problems indication	36 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: David Chung-Wah Siu, Professor, The Universtiy of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2017
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Lung Diseases; Hypertension; Lupus Erythematosus, Systemic; Scleroderma, Systemic; Scleroderma, Diffuse; Hypertension, Pulmonary; Connective Tissue Diseases
• Other Study ID Numbers: PH_Screening_1.4.2017 ver.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No