Connective Tissue Disease Patients With Pulmonary Hypertension

NCT ID: NCT05980728

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2030-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Connective Tissue Diseases Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Connective Tissue Disease Patients With Pulmonary Hypertension

Connective Tissue Disease Patients With Pulmonary Hypertension

No Intervention

Intervention Type OTHER

No Intervention

Connective Tissue Disease Patients Without Pulmonary Hypertension

Connective Tissue Disease Patients Without Pulmonary Hypertension

No Intervention

Intervention Type OTHER

No Intervention

healthy

healthy people

No Intervention

Intervention Type OTHER

No Intervention

Interventions

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No Intervention

No Intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qiang Wang, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Central Contacts

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Qiang Wang, MD

Role: CONTACT

+862568307588

References

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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.

Reference Type DERIVED
PMID: 40188059 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39792031 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38323656 (View on PubMed)

Other Identifiers

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JSPH cohort

Identifier Type: -

Identifier Source: org_study_id

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