Pulmonary HypertensionCHA-RHCNCT06954727
China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization
An observational study of Pulmonary Hypertension and Pulmonary Embolism (Diagnosis), run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Right heart catheterization(RHC) plays a crucial role in the diagnosis and treatment of pulmonary vascular diseases(PVD). In China, the lack of equipment and technical expertise has historically limited the implementation of RHC, thereby greatly restricting the diagnosis and treatment of RVD. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Embolism (Diagnosis), Pulmonary Arterial Hypertension
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2030
- How long will I take part?
- 1 Year
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent right heart catheterization for the first time due to dyspnea or suspected pulmonary hypertension and age over 14 years old
Who may be able to join
- Patients who underwent right heart catheterization for the first time due to dyspnea or suspected pulmonary hypertension
- Age ≥14 years old
Who cannot join
- Vital data missing
- Did not sign informed consent or did not agree to follow-up
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
Zhenguo Zhai, 010-8420-6265, zhaizhenguo2011@126.com
Yu Zhang, MD, 86-13120211583, zhangyuccmu2013@yeah.net
About this study
Official title: China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-A Quality Control on Right Heart Catheterization
Right heart catheterization(RHC) plays a crucial role in the diagnosis and treatment of pulmonary vascular diseases(PVD). In China, the lack of equipment and technical expertise has historically limited the implementation of RHC, thereby greatly restricting the diagnosis and treatment of RVD. In recent years, with improvements in these issues, more hospitals have acquired the capability to perform RHC. The purpose of this study is to conduct quality control of RHC across multiple pulmonary hypertension(PH) centers in China. The study population consists of patients who underwent RHC for the first time due to dyspnea or suspected PH. This study retrospectively and prospectively collects multicenter RHC data, with the main quality control contents including indications for the procedure, collection and analysis of hemodynamic data, diagnosis and treatment, and long-term management of patients.
Read the detailed description
This study is led by the China-Japan Friendship Hospital and will be conducted across approximately 30 pulmonary hypertension centers in China. It is an observational cohort study without interventional treatment. Eligible participants are patients aged 14 years or older who undergo right heart catheterization due to dyspnea or suspected pulmonary hypertension. After study initiation, investigators at each center will enroll eligible patients and collect baseline data, hemodynamic parameters from right heart catheterization, diagnostic classification of pulmonary hypertension, and treatment plans. Patients will receive routine follow-up at their respective centers, and investigators will gather follow-up data according to the study protocol. All de-identified data will be recorded in an Electronic Data Capture (EDC) system. A dedicated data management team will oversee data management, quality control, and statistical analysis.
- Conditions
- Pulmonary Hypertension, Pulmonary Embolism (Diagnosis), Pulmonary Arterial Hypertension, Right Heart Catheterization
- Being tested
- No intervention; Observational study
- Keywords
- right heart catheterization, pulmonary hypertension, pulmonary arterial hypertension, pulmonary vascular disease
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Embolism, Disease, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention; Observational studyOther
No intervention; observational study
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent right heart catheterization | The study population consists of patients who underwent right heart catheterization for the first time due to dyspnea or suspected pulmonary hypertension. No intervention. Receives: Other: No intervention; Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month all cause death
3-month all cause death
Measured: 3 month
Secondary outcomes (2)
dignosis and type of pulmonary hypertension
dignosis and type of pulmonary hypertension according to latest guidelines
Measured: 1 month
1-year all cause death
1-year all cause death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start1 Jan 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies 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
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenguo Zhai,MD,PhD, China-Japan Friendship Hospital
- Investigators
- Zhenguo Zhai, PhD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954727
- Sponsor's protocol ID
- CHALLENGE-RHC
- Other IDs
- 2023YFC2507200
- Acronym
- CHA-RHC
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We retain the property rights to the patient-level data, and therefore will not share this data. We plan to publish the study results and provide aggregate data when necessary.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-A Quality Control on Right Heart Catheterization
- ClinicalTrials.gov ID
- NCT06954727
- Acronym / sponsor ID
- CHA-RHC / CHALLENGE-RHC
- Conditions
- Pulmonary Hypertension, Pulmonary Embolism (Diagnosis), Pulmonary Arterial Hypertension, Right Heart Catheterization
- Keywords
- right heart catheterization, pulmonary hypertension, pulmonary arterial hypertension, pulmonary vascular disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 May 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.
Right heart catheterization(RHC) plays a crucial role in the diagnosis and treatment of pulmonary vascular diseases(PVD). In China, the lack of equipment and technical expertise has historically limited the implementation of RHC, thereby greatly restricting the diagnosis and treatment of RVD. In recent years, with improvements in these issues, more hospitals have acquired the capability to perform RHC. The purpose of this study is to conduct quality control of RHC across multiple pulmonary hypertension(PH) centers in China. The study population consists of patients who underwent RHC for the first time due to dyspnea or suspected PH. This study retrospectively and prospectively collects multicenter RHC data, with the main quality control contents including indications for the procedure, collection and analysis of hemodynamic data, diagnosis and treatment, and long-term management of patients.
Detailed description
This study is led by the China-Japan Friendship Hospital and will be conducted across approximately 30 pulmonary hypertension centers in China. It is an observational cohort study without interventional treatment. Eligible participants are patients aged 14 years or older who undergo right heart catheterization due to dyspnea or suspected pulmonary hypertension. After study initiation, investigators at each center will enroll eligible patients and collect baseline data, hemodynamic parameters from right heart catheterization, diagnostic classification of pulmonary hypertension, and treatment plans. Patients will receive routine follow-up at their respective centers, and investigators will gather follow-up data according to the study protocol. All de-identified data will be recorded in an Electronic Data Capture (EDC) system. A dedicated data management team will oversee data management, quality control, and statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent right heart catheterization | – | Other: No intervention; Observational studyThe study population consists of patients who underwent right heart catheterization for the first time due to dyspnea or suspected pulmonary hypertension. No intervention. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent right heart catheterization for the first time due to dyspnea or suspected pulmonary hypertension and age over 14 years old
Key inclusion criteria (2 listed)
- Patients who underwent right heart catheterization for the first time due to dyspnea or suspected pulmonary hypertension
- Age ≥14 years old
Key exclusion criteria (2 listed)
- Vital data missing
- Did not sign informed consent or did not agree to follow-up
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 |
|---|---|---|
| No intervention; Observational studyNo intervention; observational study | Other | Patients who underwent right heart catheterization |
Primary outcome
3-month all cause death
Time frame: 3 month
3-month all cause death
2 secondary outcomes
dignosis and type of pulmonary hypertension
Time frame: 1 month
1-year all cause death
Time frame: 1 year
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 21 May 2025.
- Individual participant dataSharing planned: No. We retain the property rights to the patient-level data, and therefore will not share this data. We plan to publish the study results and provide aggregate data when necessary.
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
Zhenguo Zhai, PhD principal investigator
China-Japan Friendship Hospital
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 Pulmonary Hypertension and Pulmonary Embolism (Diagnosis), 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 2 inclusion and 2 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 21 May 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 Zhenguo Zhai (010-8420-6265, zhaizhenguo2011@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-month all cause death (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2025.