Connective Tissue DiseasesNCT05980728
Connective Tissue Disease Patients With Pulmonary Hypertension
An observational study of Connective Tissue Diseases and Pulmonary Hypertension, run by The First Affiliated Hospital with Nanjing Medical University.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Connective Tissue Diseases, Pulmonary Hypertension
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Sep 2030
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Connective Tissue Disease Patients With Pulmonary Hypertension
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Prognostic Value of Biomarker in Connective Tissue Disease Patients With Pulmonary Hypertension
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.
- Conditions
- Connective Tissue Diseases, Pulmonary Hypertension
- Being tested
- No Intervention
- Keywords
- prognosis , biomarker, pulmonary hypertension
- Medical subject headings
- Connective Tissue Diseases, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Connective Tissue Disease Patients With Pulmonary Hypertension | Connective Tissue Disease Patients With Pulmonary Hypertension Receives: Other: No Intervention | |
| Connective Tissue Disease Patients Without Pulmonary Hypertension | Connective Tissue Disease Patients Without Pulmonary Hypertension Receives: Other: No Intervention | |
| healthy | healthy people Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
number of participants with All cause death
Measured: 30 years
Secondary outcomes (1)
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.
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Connective Tissue DiseasesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Wang, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980728
- Sponsor's protocol ID
- JSPH cohort
- Status last verified
- Oct 2023
- First submitted
- 3 Jul 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dai J, Ma L, Zhang Y, Shan L, Li D, Li L, Hu Q, Zhou Z, Sun X, Wang Q, Zhou L. The prognostic value of HFA-PEFF score in connective tissue disease-associated PAH: evidence from a cohort study. BMC Cardiovasc Disord. 2025 Apr 5;25(1):258. doi: 10.1186/s12872-025-04691-y.
PubMed 40188059Sun X, Zhang Y, Liu T, Zhang H, Zu B, Zhou L, Wang Q, Zhang M. Clinical characteristics of primary SS- and overlap SS-associated pulmonary arterial hypertension: a multicentre retrospective study. Rheumatology (Oxford). 2025 Jun 1;64(6):3618-3625. doi: 10.1093/rheumatology/keaf013.
PubMed 39792031Dai J, Liu T, Zhang H, Sun X, Tang Y, Qian W, Zhang Y, Ye H, Shan L, Li L, Du M, Li D, Zhu Y, Ma K, Liu L, Wang Q, Zhou L. Fragmented QRS complex could predict all-cause mortality in patients with connective tissue disease-associated pulmonary arterial hypertension. Rheumatology (Oxford). 2025 Feb 1;64(2):789-797. doi: 10.1093/rheumatology/keae084.
PubMed 38323656
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of Biomarker in Connective Tissue Disease Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT05980728
- Acronym / sponsor ID
- JSPH cohort
- Conditions
- Connective Tissue Diseases, Pulmonary Hypertension
- Keywords
- prognosis , biomarker, pulmonary hypertension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Connective Tissue Disease Patients With Pulmonary Hypertension | – | Other: No InterventionConnective Tissue Disease Patients With Pulmonary Hypertension |
| Connective Tissue Disease Patients Without Pulmonary Hypertension | – | Other: No InterventionConnective Tissue Disease Patients Without Pulmonary Hypertension |
| healthy | – | Other: No Interventionhealthy people |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Connective Tissue Disease Patients With Pulmonary Hypertension
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Other | Connective Tissue Disease Patients With Pulmonary Hypertension, Connective Tissue Disease Patients Without Pulmonary Hypertension, healthy |
Primary outcome
Death
Time frame: 30 years
number of participants with All cause death
1 secondary outcome
Clinical worsening
Time frame: 30 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Derived from this study: PubMed 40188059Dai J, Ma L, Zhang Y, Shan L, Li D, Li L, Hu Q, Zhou Z, Sun X, Wang Q, Zhou L. The prognostic value of HFA-PEFF score in connective tissue disease-associated PAH: evidence from a cohort study. BMC Cardiovasc Disord. 2025 Apr 5;25(1):258. doi: 10.1186/s12872-025-04691-y.
- Derived from this study: PubMed 39792031Sun X, Zhang Y, Liu T, Zhang H, Zu B, Zhou L, Wang Q, Zhang M. Clinical characteristics of primary SS- and overlap SS-associated pulmonary arterial hypertension: a multicentre retrospective study. Rheumatology (Oxford). 2025 Jun 1;64(6):3618-3625. doi: 10.1093/rheumatology/keaf013.
- Derived from this study: PubMed 38323656Dai J, Liu T, Zhang H, Sun X, Tang Y, Qian W, Zhang Y, Ye H, Shan L, Li L, Du M, Li D, Zhu Y, Ma K, Liu L, Wang Q, Zhou L. Fragmented QRS complex could predict all-cause mortality in patients with connective tissue disease-associated pulmonary arterial hypertension. Rheumatology (Oxford). 2025 Feb 1;64(2):789-797. doi: 10.1093/rheumatology/keae084.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qiang Wang, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Connective Tissue Diseases and Pulmonary Hypertension, run by The First Affiliated Hospital with Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiang Wang, MD (+862568307588, jerrytortoise@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 30 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05980728, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.