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

Recruiting

• Conditions: Takayasu Arteritis With Pulmonary Artery Involvement; Pulmonary Arterial Hypertension Associated With Connective Tissue Disease

• Registration Number: NCT07184814
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

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).

Detailed Description

The present study intends to conduct a prospective analysis of the clinical data in TAK patients in order to:

1. describe the clinical characteristics and current status of multimodal treatment in patients with TAK-PAI, thereby enhancing the understanding of TAK-PAI;

2. to investigate the risk factors for mortality in patients with TAK-PAI, so as to promote early intervention and reduce mortality.

3. explore factors associated with pulmonary hypertention (PH) in patients with TAK-PAI, so as to facilitate the early identification of patients who may develop PH.

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause death	At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026.

Secondary Outcome Measures

Name	Time	Method
Six-minute walk distance	At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026
WHO functional class	At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026.
N-terminal pro-brain natriuretic peptide level	At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026

Trial Locations

Locations (1)

China-Japan Friendship hospital; 🇨🇳 Beijing, Beijing Municipality, China