Takayasu Arteritis With Pulmonary Artery InvolvementCAPTAINNCT07184814
Clinical Features and Prognosis of Takayasu's Arteritis With Pulmonary Arteries Involvement
An observational study of Takayasu Arteritis With Pulmonary Artery Involvement and Pulmonary Arterial Hypertension Associated With Connective Tissue Disease, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Takayasu Arteritis With Pulmonary Artery Involvement, Pulmonary Arterial Hypertension Associated With Connective Tissue Disease
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: TAK patients hospitalized at the China-Japan Friendship Hospital, Beijing Anzhen Hospital and Beijing Chaoyang Hospital.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship hospital
Beijing, Beijing Municipality, 100029
Wanmu Xie, Doctor, 15611734410, xiewanmu@126.com
About this study
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).
Read the detailed description
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TAK-PAI group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
Measured: At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026.
Secondary outcomes (3)
Six-minute walk distance
Measured: At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026
WHO functional class
Measured: At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026.
N-terminal pro-brain natriuretic peptide level
Measured: At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Jan 2016
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Takayasu Arteritis With Pulmonary Artery InvolvementStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wanmu Xie, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184814
- Sponsor's protocol ID
- 2022-NHLHCRF-LX-01-01-02
- Acronym
- CAPTAIN
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang J, Zheng S, Yiminniyaze R, Zheng H, Zhang S, Tian H, Kong Y, Xie W, Huang Q, Zhai Z. Association Between Serum Uric Acid and Pulmonary Hypertension in Takayasu Arteritis With Pulmonary Artery Involvement: A Cross-Sectional Study. Pulm Circ. 2026 Sep 15;16(3):e70393. doi: 10.1002/pul2.70393. eCollection 2026 Jul.
PubMed 42746108Zheng S, Li Y, Liu Z, Chen Y, Song Y, Zhang S, Xie W, Zhai Z. Pulmonary hypertension in Takayasu arteritis with pulmonary artery involvement: risk factors and impact on mortality. BMJ Open Respir Res. 2026 Apr 1;13(1):e003854. doi: 10.1136/bmjresp-2025-003854.
PubMed 41922023
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features and Prognosis of Takayasu's Arteritis With Pulmonary Arteries Involvement
- ClinicalTrials.gov ID
- NCT07184814
- Acronym / sponsor ID
- CAPTAIN / 2022-NHLHCRF-LX-01-01-02
- Conditions
- Takayasu Arteritis With Pulmonary Artery Involvement, Pulmonary Arterial Hypertension Associated With Connective Tissue Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-PAI group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- TAK patients hospitalized at the China-Japan Friendship Hospital, Beijing Anzhen Hospital and Beijing Chaoyang Hospital.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause death
Time frame: At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026.
3 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Derived from this study: PubMed 42746108Wang J, Zheng S, Yiminniyaze R, Zheng H, Zhang S, Tian H, Kong Y, Xie W, Huang Q, Zhai Z. Association Between Serum Uric Acid and Pulmonary Hypertension in Takayasu Arteritis With Pulmonary Artery Involvement: A Cross-Sectional Study. Pulm Circ. 2026 Sep 15;16(3):e70393. doi: 10.1002/pul2.70393. eCollection 2026 Jul.
- Derived from this study: PubMed 41922023Zheng S, Li Y, Liu Z, Chen Y, Song Y, Zhang S, Xie W, Zhai Z. Pulmonary hypertension in Takayasu arteritis with pulmonary artery involvement: risk factors and impact on mortality. BMJ Open Respir Res. 2026 Apr 1;13(1):e003854. doi: 10.1136/bmjresp-2025-003854.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Takayasu Arteritis With Pulmonary Artery Involvement and Pulmonary Arterial Hypertension Associated With Connective Tissue Disease, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanmu Xie, Doctor (15611734410, xiewanmu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death (time frame: At 3 months, 6 months, and annually thereafter following enrollment, until December 31, 2026.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07184814, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.