Connective Tissue Disease Patients With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

The Prognostic Value of Biomarker in Connective Tissue Disease Patients With Pulmonary Hypertension

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05980728
• Other study ID #: JSPH cohort
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: September 1, 2030

Study information

• Verified date: October 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Qiang Wang, MD
• Phone: +862568307588
• Email: jerrytortoise[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: September 1, 2030
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	number of participants with All cause death	30 years
Secondary	Clinical worsening	number of participants with Hospitalization for worsening pulmonary arterial hypertension(PAH),lung or heart/lung transplant) or unsatisfactory long-term clinical response (the 6-minute walk distance decreased > 15% from baseline and World Health Organization(WHO) functional class III/IV symptoms assessed at two clinic visits separated by > 6 months after sufficient PAH targeted drug treatment.	30 years