Connective Tissue Disease Patients With Pulmonary Hypertension

Study Purpose

Adult patients with suspected or confirmed Connective Tissue Disease Patients (CTD)With Pulmonary Hypertension(PH)will be recruited. Patients will be approached, consented, have baseline demographics, diagnostics and disease activity measures recorded, and blood taken. The collection of data and biological material will mirror usual clinical practice as far as possible. Subjects will ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures recorded and questionnaires completed.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Definite diagnosis of CTD included Systemic lupus erythematosus（SLE） diagnosed according to the 2019 The European Alliance of Associations for Rheumatology（EULAR） criteria, primary Sjogren's syndrome (pSS) defined according to the 2016 American College of Rheumatology(ACR) criteria, Systemic Sclerosis(SSc) defined according to the 2013 ACR criteria, mixed connective tissue disease (MCTD) defined by Sharp criteria, and Rheumatoid Arthritis(RA) defined according 2010 ACR criteria of two or more CTD at the same time were defined as having overlap syndrome (OS).

Patients who had clinical and serological manifestations suggestive of systemic autoimmune diseases but did not fulfil the classification criteria for CTD were defined as having undifferentiated CTD (UCTD).

- PAH was diagnosed by right heart catheterization was defined as mean Pulmonary Artery Pressure (mPAP)>20 Millimeters of mercury（mmHg）, Pulmonary Artery Wedge Pressure（PAWP）≤15mmHg, Pulmonary Vascular Resistance（PVR）>2 Wood.

Exclusion Criteria:

- significant interstitial lung disease or chronic obstructive pulmonary disease; - left heart disease or congenital heart disease associated with pulmonary hypertension; - chronic thromboembolic pulmonary hypertension; - portal hypertension; - drug or toxin exposure; - HIV infection; - any other diseases known to be associated with PAH; - age<18 years.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05980728
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The First Affiliated Hospital with Nanjing Medical University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Qiang Wang, MD
Principal Investigator Affiliation	The First Affiliated Hospital with Nanjing Medical University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Connective Tissue Diseases, Pulmonary Hypertension

Arms & Interventions

Arms

: Connective Tissue Disease Patients With Pulmonary Hypertension

Connective Tissue Disease Patients With Pulmonary Hypertension

: Connective Tissue Disease Patients Without Pulmonary Hypertension

Connective Tissue Disease Patients Without Pulmonary Hypertension

: healthy

healthy people

Interventions

Other: - No Intervention

No Intervention

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Qiang Wang, MD

jerrytortoise@163.com

+862568307588

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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