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

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ClinicalTrials.gov Identifier: NCT03446339
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. David Siu, The University of Hong Kong

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.

Condition or disease
Connective Tissue Diseases Systemic Sclerosis Systemic Lupus Erythematosus

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
Estimated Enrollment : 1800 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Territory-Wide Pulmonary Hypertension Screening Amongst Patients With Connective Tissue Diseases: A Prospective Screening Study
Actual Study Start Date : August 3, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020





Primary Outcome Measures :
  1. Prevalence of asymptomatic pulmonary hypertension in Chinese patients with connective tissue diseases [ Time Frame: 36 months ]
    Proportion of patients diagnosed to have pulmonary hypertension


Secondary Outcome Measures :
  1. Clinical predictor of Echocardiography for pulmonary hypertension in Chinese patients with connective tissue diseases [ Time Frame: 36 months ]
    Cardiac functional and structural data for pulmonary hypertension detection

  2. Clinical predictor of BNP assay for pulmonary hypertension in Chinese patients with connective tissue diseases [ Time Frame: 36 months ]
    Cardiac marker for cardiac problems indication



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1,800 rheumatology patients with connective tissue diseases from public hospitals within Hospital Authority of Hong Kong
Criteria

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


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): NCT03446339


Contacts
Contact: David Chung-Wah Siu, Professor +852-22554694 cwdsiu@hku.hk

Locations
China
The University of Hong Kong Recruiting
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: David Chung-Wah Siu, Professor The Universtiy of Hong Kong

Responsible Party: Dr. David Siu, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03446339     History of Changes
Other Study ID Numbers: PH_Screening_1.4.2017 ver.1
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lupus Erythematosus, Systemic
Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases