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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03184727
Other study ID # 2016YFC1304405
Secondary ID
Status Recruiting
Phase N/A
First received June 8, 2017
Last updated June 13, 2017
Start date June 15, 2017
Est. completion date December 31, 2020

Study information

Verified date June 2017
Source Chinese Academy of Medical Sciences, Fuwai Hospital
Contact Jianguo He He, MD
Phone 80-10-88398060
Email hejianguofw@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The pulmonary vasculopathy and right heart dysfunction in COPD are drawing increasing attention these days. Recent researches show that pulmonary vasculopathy and right heart dysfunction relate to greater severity in COPD. Applying appropriate modalities for early detection of pulmonary vasculopathy and right heart dysfunction is of great importance. What's more, the interaction mechanism between pulmonary vasculature, right heart and COPD still needs to be further studied. The aim of our study is to develop an assessment system of pulmonary vasculopathy and right heart dysfunction in COPD patients and elucidate their impact on COPD course and outcome.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria:

- stable COPD patients

Exclusion Criteria:

- patents with other respiratory diseases and pulmonary hypertension other than group 3 PH;

- psychopath, addict or patients not able to coordinate;

- patients in pregnancy or breastfeeding;

- patients with limited life expectancy;

- patients with contraindiction for MRI or PET;

- patients having cerebrovascular events in 3 months;

- unstable COPD patients

Study Design


Locations

Country Name City State
China Cardiovascular Institute and Fu Wai Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality survival rate in % 3 years
Secondary COPD exacerbations total times 3 year
Secondary GOLD degree ?-? according to the pulmonary function 3 year
Secondary NYHA degree ?-? according to the symptom 3 year
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