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NCT Number: NCT07184814

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

China-Japan Friendship hospital

Beijing, Beijing Municipality, 100029, China

Location status: Recruiting

Location contact

Wanmu Xie, Doctor

CONTACT

[email protected]

15611734410

About this study

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

  • describe the clinical characteristics and current status of multimodal treatment in patients with TAK-PAI, thereby enhancing the understanding of TAK-PAI;
  • to investigate the risk factors for mortality in patients with TAK-PAI, so as to promote early intervention and reduce mortality.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. All-cause death

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

Secondary outcomes

  1. Six-minute walk distance

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

  2. WHO functional class

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

  3. 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

  1. Mean pulmonary arterial pressure assessed by right heart catheterization

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

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

  2. Pulmonary vascular resistance assessed by right heart catheterization

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

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

  3. Cardiac output assessed by right heart catheterization

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

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

  4. Cardiac index assessed by right heart catheterization

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Wanmu Xie, Doctor

CONTACT

[email protected]

15611734410

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Acronym: CAPTAIN

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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