Pulmonary Arterial Hypertension (PAH)NCT07570615
Development and Validation of a Chinese Quality of Life Scale for Pulmonary Arterial Hypertension
An observational study of Pulmonary Arterial Hypertension (PAH) and Quality of Life, run by Chinese Pulmonary Vascular Disease Research Group.
Trial summary
This study aims to develop and validate a culturally appropriate, reliable, and clinically applicable patient-reported outcome (PRO) instrument to assess quality of life in patients with pulmonary arterial hypertension (PAH) in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH), Quality of Life, Patients Reported Outcomes
- What is being tested?
- Questionnaire Assessment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Apr 2029
- 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: Adult patients diagnosed with pulmonary arterial hypertension receiving routine clinical care in tertiary hospitals in China.
Who may be able to join
- Age ≥18 years
- Diagnosed with pulmonary arterial hypertension
- Able to read and complete questionnaires
- Provided informed consent
Who cannot join
- Severe physical condition preventing participation
- History of psychiatric disorders or current use of psychiatric medication
- Pregnancy or lactation
- Any condition preventing completion of questionnaires
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development and Validation of a Chinese Patient-Reported Outcome Measure for Quality of Life in Pulmonary Arterial Hypertension Patients
This study aims to develop and validate a culturally appropriate, reliable, and clinically applicable patient-reported outcome (PRO) instrument to assess quality of life in patients with pulmonary arterial hypertension (PAH) in China.
The study includes two phases: (1) scale development using literature review, Delphi expert consultation, and patient interviews; and (2) multicenter prospective observational validation to evaluate reliability, validity, and responsiveness.
The final scale is expected to support clinical assessment, treatment monitoring, and health policy decision-making.
Read the detailed description
This is a multicenter, prospective observational study conducted in China to develop and validate a disease-specific quality of life scale for patients with pulmonary arterial hypertension (PAH).
The study consists of two main stages. The first stage involves item generation and selection based on literature review, expert consensus using the Delphi method, and patient interviews. The second stage includes multicenter validation to assess psychometric properties of the scale.
Participants will complete questionnaires at baseline, 1-2 weeks (for test-retest reliability), and 3 months (for responsiveness). Clinical data such as WHO functional class, 6-minute walk distance, and NT-proBNP will also be collected.
Psychometric evaluation includes internal consistency, construct validity, convergent and discriminant validity, and responsiveness. The study aims to establish a standardized, culturally adapted QoL assessment tool for Chinese PAH patients.
- Being tested
- Questionnaire Assessment
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AssessmentOther
Participants complete quality of life questionnaires and clinical data are collected. No therapeutic intervention is applied.
| Study group | Role | What they receive |
|---|---|---|
| PAH Patients | Patients diagnosed with pulmonary arterial hypertension participating in a prospective observational study and completing quality of life questionnaires. Receives: Other: Questionnaire Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric properties of the PAH-QoL scale
Evaluation of the psychometric properties of the PAH-specific quality of life scale, including internal consistency (Cronbach's alpha), test-retest reliability (intraclass correlation coefficient), and construct validity assessed by factor analysis.
Measured: Up to 3 months
Secondary outcomes (2)
Correlation with clinical parameters
Association between quality of life scores and clinical indicators, including WHO functional class and 6-minute walk distance.
Measured: Up to 3 months
Responsiveness of the PAH-QoL scale
Ability of the scale to detect changes in patient condition over time.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570615
- Sponsor's protocol ID
- China PAH-QoL Study
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy concerns and institutional data protection policies. De-identified data may be available from the corresponding author upon reasonable request.
Publications
Yarlas A, Mathai SC, Nathan SD, DuBrock HM, Morland K, Anderson N, Kosinski M, Lin X, Classi P. Considerations When Selecting Patient-Reported Outcome Measures for Assessment of Health-Related Quality of Life in Patients With Pulmonary Hypertension: A Narrative Review. Chest. 2022 Nov;162(5):1163-1175. doi: 10.1016/j.chest.2022.08.2206. Epub 2022 Aug 23.
PubMed 35998707McCollister D, Shaffer S, Badesch DB, Filusch A, Hunsche E, Schuler R, Wiklund I, Peacock A; IRB information for the 5 clinical sites. Development of the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT(R)) questionnaire: a new patient-reported outcome instrument for PAH. Respir Res. 2016 Jun 14;17(1):72. doi: 10.1186/s12931-016-0388-6.
PubMed 27301413Rose SW, Highland KB, Kelkar AA. Clinical Utility of Patient-Reported Outcome Instruments in the Management of Pulmonary Hypertension: A Systematic Review. JACC Heart Fail. 2024 Feb;12(2):366-376. doi: 10.1016/j.jchf.2023.09.008. Epub 2023 Oct 25.
PubMed 37897461
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Chinese Patient-Reported Outcome Measure for Quality of Life in Pulmonary Arterial Hypertension Patients
- ClinicalTrials.gov ID
- NCT07570615
- Acronym / sponsor ID
- China PAH-QoL Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research GroupUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 6 May 2026 (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.
This study aims to develop and validate a culturally appropriate, reliable, and clinically applicable patient-reported outcome (PRO) instrument to assess quality of life in patients with pulmonary arterial hypertension (PAH) in China.
The study includes two phases: (1) scale development using literature review, Delphi expert consultation, and patient interviews; and (2) multicenter prospective observational validation to evaluate reliability, validity, and responsiveness.
The final scale is expected to support clinical assessment, treatment monitoring, and health policy decision-making.
Detailed description
This is a multicenter, prospective observational study conducted in China to develop and validate a disease-specific quality of life scale for patients with pulmonary arterial hypertension (PAH).
The study consists of two main stages. The first stage involves item generation and selection based on literature review, expert consensus using the Delphi method, and patient interviews. The second stage includes multicenter validation to assess psychometric properties of the scale.
Participants will complete questionnaires at baseline, 1-2 weeks (for test-retest reliability), and 3 months (for responsiveness). Clinical data such as WHO functional class, 6-minute walk distance, and NT-proBNP will also be collected.
Psychometric evaluation includes internal consistency, construct validity, convergent and discriminant validity, and responsiveness. The study aims to establish a standardized, culturally adapted QoL assessment tool for Chinese PAH patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAH Patients | – | Other: Questionnaire AssessmentPatients diagnosed with pulmonary arterial hypertension participating in a prospective observational study and completing quality of life questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with pulmonary arterial hypertension receiving routine clinical care in tertiary hospitals in China.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Diagnosed with pulmonary arterial hypertension
- Able to read and complete questionnaires
- Provided informed consent
Key exclusion criteria (4 listed)
- Severe physical condition preventing participation
- History of psychiatric disorders or current use of psychiatric medication
- Pregnancy or lactation
- Any condition preventing completion of questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire AssessmentParticipants complete quality of life questionnaires and clinical data are collected. No therapeutic intervention is applied. | Other | PAH Patients |
Primary outcome
Psychometric properties of the PAH-QoL scale
Time frame: Up to 3 months
Evaluation of the psychometric properties of the PAH-specific quality of life scale, including internal consistency (Cronbach's alpha), test-retest reliability (intraclass correlation coefficient), and construct validity assessed by factor analysis.
2 secondary outcomes
Correlation with clinical parameters
Time frame: Up to 3 months
Responsiveness of the PAH-QoL scale
Time frame: Baseline to 3 months
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 27 Oct 2026.
- Background: PubMed 35998707Yarlas A, Mathai SC, Nathan SD, DuBrock HM, Morland K, Anderson N, Kosinski M, Lin X, Classi P. Considerations When Selecting Patient-Reported Outcome Measures for Assessment of Health-Related Quality of Life in Patients With Pulmonary Hypertension: A Narrative Review. Chest. 2022 Nov;162(5):1163-1175. doi: 10.1016/j.chest.2022.08.2206. Epub 2022 Aug 23.
- Background: PubMed 27301413McCollister D, Shaffer S, Badesch DB, Filusch A, Hunsche E, Schuler R, Wiklund I, Peacock A; IRB information for the 5 clinical sites. Development of the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT(R)) questionnaire: a new patient-reported outcome instrument for PAH. Respir Res. 2016 Jun 14;17(1):72. doi: 10.1186/s12931-016-0388-6.
- Background: PubMed 37897461Rose SW, Highland KB, Kelkar AA. Clinical Utility of Patient-Reported Outcome Instruments in the Management of Pulmonary Hypertension: A Systematic Review. JACC Heart Fail. 2024 Feb;12(2):366-376. doi: 10.1016/j.jchf.2023.09.008. Epub 2023 Oct 25.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy concerns and institutional data protection policies. De-identified data may be available from the corresponding author upon reasonable request.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension (PAH) and Quality of Life, run by Chinese Pulmonary Vascular Disease Research Group.
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 4 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Qin Luo (13581777615, luoqin2009@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric properties of the PAH-QoL scale (time frame: Up to 3 months). 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 NCT07570615, which also lists 3 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 27 Oct 2026.