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
|Condition or disease|
|Connective Tissue Diseases Systemic Sclerosis Systemic Lupus Erythematosus|
- 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
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.
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|
|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|
- Prevalence of asymptomatic pulmonary hypertension in Chinese patients with connective tissue diseases [ Time Frame: 36 months ]Proportion of patients diagnosed to have pulmonary hypertension
- 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
- 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
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
|Contact: David Chung-Wah Siu, Professorfirstname.lastname@example.org|
|The University of Hong Kong||Recruiting|
|Hong Kong, China|
|Principal Investigator:||David Chung-Wah Siu, Professor||The Universtiy of Hong Kong|