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Not yet recruitingNCT05980728Updated Oct 17, 2023

Connective Tissue Disease Patients With Pulmonary Hypertension

An observational study in Connective Tissue Diseases and Pulmonary Hypertension, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-17.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Connective Tissue Diseases
  • Pulmonary Hypertension

Keywords

  • prognosis , biomarker, pulmonary hypertension
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In context

Connective Tissue Diseases

154 studies on the registry are indexed under Connective Tissue Diseases; 61 are open to participants now.

This study's planned enrollment of 500 is above the median of 255 across 50 observational studies indexed under Connective Tissue Diseases.

Browse Connective Tissue Diseases studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 563 studies on the registry; 311 are open to participants now.

Browse The First Affiliated Hospital with Nanjing Medical University studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Connective Tissue Disease Patients With Pulmonary Hypertension

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
20 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Connective Tissue Disease Patients With Pulmonary Hypertension

    Connective Tissue Disease Patients With Pulmonary Hypertension

    Other: No Intervention

  • Connective Tissue Disease Patients Without Pulmonary Hypertension

    Connective Tissue Disease Patients Without Pulmonary Hypertension

    Other: No Intervention

  • healthy

    healthy people

    Other: No Intervention

Interventions

  • OtherNo Intervention

    No Intervention

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What researchers measure

Primary outcomes

  1. Death

    number of participants with All cause death

    Time frame: 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.

    Time frame: 30 years

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Study locations

No study locations are listed for this record.

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References and documents

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 40188059 ↗
  • Sun 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 39792031 ↗
  • Dai 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05980728
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Sponsor
First posted
Aug 8, 2023
Start date
Nov 1, 2023 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2030 (estimated)
Last update
Oct 17, 2023

Study contacts

Qiang Wang, MD
Contact
jerrytortoise@163.com
+862568307588
Qiang Wang, MD
principal investigator · The First Affiliated Hospital with Nanjing Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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