NCT05980728Not yet recruiting
Connective Tissue Disease Patients With Pulmonary Hypertension
The Prognostic Value of Biomarker in Connective Tissue Disease Patients With Pulmonary Hypertension
Source: ClinicalTrials.gov · Last updated 17 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 3 Jul 2023
- Start date
- Nov 2023
- Primary completion date
- Sept 2027
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- NCT number
- NCT05980728
What you commit to
- Study type: Observational
- Planned participants: 500
- From Nov 2023 to the primary completion date, Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- drug or toxin exposure;
Other illness
- 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;
- HIV infection;
- any other diseases known to be associated with PAH;
Age
- age\<18 years.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.