Clinical Features and Prognosis of Takayasu's Arteritis With Pulmonary Arteries Involvement

ConditionsTakayasu Arteritis With Pulmonary Artery Involvement Pulmonary Arterial Hypertension Associated With Connective Tissue Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorChina-Japan Friendship Hospital

About this trial

The purpose of this study is to identify the clinical features, management pattern and long-term outcomes of patients with pulmonary arteries involvement in Takayasu's arteritis (TAK-PAI).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hospitalized between Jan 1, 2016 and Dec 31, 2026

Diagnosed with TAK according to the modified Ishikawa criteria and/or 1990 American College of Rheumatology criteria and/or 2022 ACR/EULAR criteria

Diagnosed with pulmonary artery involvement using computed tomography pulmonary angiography or transcatheter pulmonary angiography

Patients without aortic or primary branch involvement who nonetheless exhibited both clinical features and computed tomography-confirmed evidence of pulmonary artery involvement (PAI), after exclusion of other diseases causing pulmonary artery stenosis or occlusion

Disqualifiers

Patients with PAI caused by non-TAK diseases such as other types of vasculitis, fibrosing mediastinitis, pulmonary artery sarcoma, pulmonary sarcoidosis or chronic thromboembolic pulmonary hypertension

Trial population

TAK patients hospitalized at the China-Japan Friendship Hospital, Beijing Anzhen Hospital and Beijing Chaoyang Hospital.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants

are grouped into 1 trial group

Group A: TAK-PAI group

Trial outcomes

Primary outcomes

All-cause death

Time frame

At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026.

Secondary outcomes

Six-minute walk distance

Time frame

At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026

WHO functional class

Time frame

At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026.

N-terminal pro-brain natriuretic peptide level

Time frame

At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026

Other outcomes

Mean pulmonary arterial pressure assessed by right heart catheterization

Hemodynamic parameters assessed by right heart catheterization in patients with pulmonary hypertension.

Time frame

At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026.

Pulmonary vascular resistance assessed by right heart catheterization

Hemodynamic parameters assessed by right heart catheterization in patients with pulmonary hypertension.

Time frame

At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026.

Cardiac output assessed by right heart catheterization

Hemodynamic parameters assessed by right heart catheterization in patients with pulmonary hypertension.

Time frame

At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026.

Cardiac index assessed by right heart catheterization

Hemodynamic parameters assessed by right heart catheterization in patients with pulmonary hypertension.

Time frame

At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China-Japan Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov

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