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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02061787
Other study ID # CPETPH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2010
Est. completion date September 8, 2030

Study information

Verified date July 2022
Source Chinese Pulmonary Vascular Disease Research Group
Contact Zhihong Liu, Doctor
Phone 8601088396590
Email zhihongliufuwai@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

cardiopulmonary exercise test evaluate patients with pulmonary hypertension before and after medical or balloon pulmonary angioplasty treatment


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


Recruitment information / eligibility

Status Recruiting
Enrollment 4000
Est. completion date September 8, 2030
Est. primary completion date September 8, 2030
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
balloon pulmonary angioplasty
patients with chronic thromboembolic pulmonary hypertension who underwent balloon pulmonary angioplasty

Locations

Country Name City State
China center of pulmonary vascular disease, Fuwai hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese Pulmonary Vascular Disease Research Group

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary all cause mortality all cause mortality 5 years
Primary mean pulmonary arterial pressure after treatment the mean pulmonary arterial pressure of patients with chronic thromboembolic pulmonary hypertension after balloon pulmonary angioplasty treatment 5 years
Primary achievement of low risk patients with chronic thromboembolic pulmonary hypertension achievement of low risk after balloon pulmonary angioplasty 5 years
Secondary deterioration of WHO function deterioration of WHO function 5 years
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