Ignite Creation Date:
2024-05-06 @ 11:09 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03446339
Status:
UNKNOWN
Last Update Posted:
2021-08-03
First Post:
2018-01-29
Brief Title:
Pulmonary Hypertension Screening for Rheumatology Patients SOPHIE
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Territory-Wide Pulmonary Hypertension Screening Amongst Patients With Connective Tissue Diseases A Prospective Screening Study
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAH
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 andor 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
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 ESCEuropean 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 Students t test or Fishers exact test as appropriate The outcomes would be analyzed
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 ESCEuropean 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 Students t test or Fishers exact test as appropriate The outcomes would be analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None