Pulmonary HypertensionCPETPHNCT02061787
the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension
An observational study of Pulmonary Hypertension and Chronic Thromboembolic Pulmonary Hypertension, run by Chinese Pulmonary Vascular Disease Research Group at 1 site in China.
Trial summary
cardiopulmonary exercise test evaluate patients with pulmonary hypertension before and after medical or balloon pulmonary angioplasty treatment Read more about this study
- Who is it for?
- Ages 5 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Arterial Hypertension Associated With Schistosomiasis (Disorder)
- What is being tested?
- balloon pulmonary angioplasty
- Type of treatment
- Medical device
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to 8 Sep 2030
- How long will I take part?
- 5 Years
- 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 5 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: pulmonary hypertension who may accomplish cardiopulmonary exercise testing.
Who may be able to join
- pulmonary arterial hypertension;( WHO1)
- chronic thromboembolic pulmonary hypertension;
- pulmonary arterial hypertension due to other cause;
Who cannot join
- massive hemoptysis;
- unable to accomplish cardiopulmonary exercise testing due to neuromuscular disorders;
- recent recurrent syncope;
- pulmonary hypertension due to hypoxia;
- pulmonary hypertension due to left heart diseases.
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
center of pulmonary vascular disease, Fuwai hospital
Beijing, 100037
Xiuping Ma, 8601088396816, zhihongliufuwai@163.com
Zhihong Liu, MD,PhD
About this study
cardiopulmonary exercise test evaluate patients with pulmonary hypertension before and after medical or balloon pulmonary angioplasty treatment
Read the detailed description
patients diagnosed with pulmonary hypertension, including pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, will be evaluated by cardio pulmonary exercise test before and after medical or balloon pulmonary angioplasty treatment
- Conditions
- Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Arterial Hypertension Associated With Schistosomiasis (Disorder)
- Being tested
- balloon pulmonary angioplasty
- Keywords
- Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Arterial Hypertension, balloon pulmonary angioplasty, cardiopulmonary exercise test
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon pulmonary angioplastyDevice
patients with chronic thromboembolic pulmonary hypertension who underwent balloon pulmonary angioplasty
| Study group | Role | What they receive |
|---|---|---|
| cardiopulmonary exercise testing | patients diagnosed with pulmonary hypertension, including pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension, were evaluated by cardiopulmonary exercise testing before and after medical or balloon pulmonary angioplasty treatment Receives: Device: balloon pulmonary angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
all cause mortality
Measured: 5 years
mean pulmonary arterial pressure after treatment
the mean pulmonary arterial pressure of patients with chronic thromboembolic pulmonary hypertension after balloon pulmonary angioplasty treatment
Measured: 5 years
achievement of low risk
patients with chronic thromboembolic pulmonary hypertension achievement of low risk after balloon pulmonary angioplasty
Measured: 5 years
Secondary outcomes (1)
deterioration of WHO function
deterioration of WHO function
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startSep 2010
- Primary completion8 Sep 2030 (estimated)
- Study completion8 Sep 2030 (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 Pulmonary HypertensionStudies 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
- 4,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhihong Liu, MD，PhD, Study director, Fuwai Hospital, National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061787
- Sponsor's protocol ID
- CPETPH
- Acronym
- CPETPH
- Status last verified
- Jul 2022
- First submitted
- 11 Feb 2014
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Li X, Duan A, Jin Q, Zhang Y, Luo Q, Zhao Q, Yan L, Huang Z, Hu M, Xiong C, Zhao Z, Liu Z. Exercise feature and predictor of prognosis in patients with pulmonary artery stenosis-associated pulmonary hypertension. ESC Heart Fail. 2022 Dec;9(6):4198-4208. doi: 10.1002/ehf2.14154. Epub 2022 Sep 13.
PubMed 36101502Tang Y, Yao L, Liu Z, Ma X, Luo Q, Zhao Z, Huang Z, Tu L, Gao L, Jin Q, Ni X, Xiong C. Effect of calcium channel blockers evaluated by cardiopulmonary exercise testing in idiopathic pulmonary arterial hypertension responding to acute pulmonary vasoreactivity testing. Pulm Pharmacol Ther. 2017 Apr;43:26-31. doi: 10.1016/j.pupt.2017.01.012. Epub 2017 Feb 1.
PubMed 28159512
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02061787
- Acronym / sponsor ID
- CPETPH / CPETPH
- Conditions
- Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Arterial Hypertension Associated With Schistosomiasis (Disorder)
- Keywords
- Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Arterial Hypertension, balloon pulmonary angioplasty, cardiopulmonary exercise test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research GroupUniversity, hospital or other
- Study start
- Sep 2010 (actual)
- Primary completion
- 8 Sep 2030 (estimated)
- Study completion
- 8 Sep 2030 (estimated)
- First posted
- 13 Feb 2014 (estimated)
- 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.
cardiopulmonary exercise test evaluate patients with pulmonary hypertension before and after medical or balloon pulmonary angioplasty treatment
Detailed description
patients diagnosed with pulmonary hypertension, including pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, will be evaluated by cardio pulmonary exercise test before and after medical or balloon pulmonary angioplasty treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiopulmonary exercise testing | – | Device: balloon pulmonary angioplastypatients diagnosed with pulmonary hypertension, including pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension, were evaluated by cardiopulmonary exercise testing before and after medical or balloon pulmonary angioplasty treatment |
Who may qualify
- Ages
- 5 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pulmonary hypertension who may accomplish cardiopulmonary exercise testing.
Key inclusion criteria (3 listed)
- pulmonary arterial hypertension;( WHO1)
- chronic thromboembolic pulmonary hypertension;
- pulmonary arterial hypertension due to other cause;
Key exclusion criteria (5 listed)
- massive hemoptysis;
- unable to accomplish cardiopulmonary exercise testing due to neuromuscular disorders;
- recent recurrent syncope;
- pulmonary hypertension due to hypoxia;
- pulmonary hypertension due to left heart diseases.
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 |
|---|---|---|
| balloon pulmonary angioplastypatients with chronic thromboembolic pulmonary hypertension who underwent balloon pulmonary angioplasty | Device | cardiopulmonary exercise testing |
Primary outcome
all cause mortality
Time frame: 5 years
all cause mortality
mean pulmonary arterial pressure after treatment
Time frame: 5 years
the mean pulmonary arterial pressure of patients with chronic thromboembolic pulmonary hypertension after balloon pulmonary angioplasty treatment
achievement of low risk
Time frame: 5 years
patients with chronic thromboembolic pulmonary hypertension achievement of low risk after balloon pulmonary angioplasty
1 secondary outcome
deterioration of WHO function
Time frame: 5 years
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 19 Sep 2024.
- Derived from this study: PubMed 36101502Li X, Duan A, Jin Q, Zhang Y, Luo Q, Zhao Q, Yan L, Huang Z, Hu M, Xiong C, Zhao Z, Liu Z. Exercise feature and predictor of prognosis in patients with pulmonary artery stenosis-associated pulmonary hypertension. ESC Heart Fail. 2022 Dec;9(6):4198-4208. doi: 10.1002/ehf2.14154. Epub 2022 Sep 13.
- Derived from this study: PubMed 28159512Tang Y, Yao L, Liu Z, Ma X, Luo Q, Zhao Z, Huang Z, Tu L, Gao L, Jin Q, Ni X, Xiong C. Effect of calcium channel blockers evaluated by cardiopulmonary exercise testing in idiopathic pulmonary arterial hypertension responding to acute pulmonary vasoreactivity testing. Pulm Pharmacol Ther. 2017 Apr;43:26-31. doi: 10.1016/j.pupt.2017.01.012. Epub 2017 Feb 1.
- Individual participant dataSharing planned: No
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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.
Zhihong Liu, MD，PhD study director
Fuwai Hospital, National Center for Cardiovascular Diseases
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 Chronic Thromboembolic Pulmonary Hypertension, run by Chinese Pulmonary Vascular Disease Research Group 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 3 inclusion and 5 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 19 Sep 2024. 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 Zhihong Liu, Doctor (8601088396590, zhihongliufuwai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 5 years). The study lists 3 primary outcomes in all. 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 NCT02061787, 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 19 Sep 2024.