NCT07184814

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 2016Dec 2026

Study Start

First participant enrolled

January 1, 2016

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

11 years

First QC Date

September 10, 2025

Last Update Submit

September 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • All-cause death

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

Secondary Outcomes (3)

  • 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

Other Outcomes (4)

  • Mean pulmonary arterial pressure assessed by right heart catheterization

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

  • Pulmonary vascular resistance assessed by right heart catheterization

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

  • Cardiac output assessed by right heart catheterization

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

  • +1 more other outcomes

Study Arms (1)

TAK-PAI group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Central Study Contacts

Wanmu Xie, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Integrative Pulmonary Medicine

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 22, 2025

Study Start

January 1, 2016

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations