- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02061787
the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension (CPETPH)
July 29, 2022 updated by: Chinese Pulmonary Vascular Disease Research Group
cardiopulmonary exercise test evaluate patients with pulmonary hypertension before and after medical or balloon pulmonary angioplasty treatment
Study Overview
Status
Recruiting
Conditions
Intervention / 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 Type
Observational
Enrollment (Anticipated)
4000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhihong Liu, Doctor
- Phone Number: 8601088396590
- Email: zhihongliufuwai@163.com
Study Locations
-
-
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Beijing, China, 100037
- Recruiting
- Center of pulmonary vascular disease, Fuwai hospital
-
Principal Investigator:
- Zhihong Liu, MD,PhD
-
Contact:
- Xiuping Ma
- Phone Number: 8601088396816
- Email: zhihongliufuwai@163.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 100 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
pulmonary hypertension who may accomplish cardiopulmonary exercise testing.
Description
Inclusion Criteria:
- pulmonary arterial hypertension;( WHO1)
- chronic thromboembolic pulmonary hypertension;
- pulmonary arterial hypertension due to other cause;
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
patients with chronic thromboembolic pulmonary hypertension who underwent balloon pulmonary angioplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
all cause mortality
Time Frame: 5 years
|
all cause mortality
|
5 years
|
|
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
|
5 years
|
|
achievement of low risk
Time Frame: 5 years
|
patients with chronic thromboembolic pulmonary hypertension achievement of low risk after balloon pulmonary angioplasty
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
deterioration of WHO function
Time Frame: 5 years
|
deterioration of WHO function
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Zhihong Liu, MD,PhD, Fuwai Hospital, National Center for Cardiovascular Diseases
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Tang 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2010
Primary Completion (Anticipated)
September 8, 2030
Study Completion (Anticipated)
September 8, 2030
Study Registration Dates
First Submitted
February 11, 2014
First Submitted That Met QC Criteria
February 11, 2014
First Posted (Estimate)
February 13, 2014
Study Record Updates
Last Update Posted (Actual)
August 2, 2022
Last Update Submitted That Met QC Criteria
July 29, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPETPH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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