- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03446339
Pulmonary Hypertension Screening for Rheumatology Patients (SOPHIE) (PAH)
Territory-Wide Pulmonary Hypertension Screening Amongst Patients With Connective Tissue Diseases: A Prospective Screening Study
Study Overview
Status
Detailed Description
Objectives:
- To detect pulmonary hypertension amongst patients with connective tissue diseases through systematic screening
- 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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: David Chung-Wah Siu, Professor
- Phone Number: +852-22554694
- Email: cwdsiu@hku.hk
Study Locations
-
-
-
Hong Kong, China
- Recruiting
- The University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Time Frame: 36 months
|
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
Time Frame: 36 months
|
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
Time Frame: 36 months
|
Cardiac marker for cardiac problems indication
|
36 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Chung-Wah Siu, Professor, The Universtiy of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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