Registry for Chronic Obstructive Pulmonary Disease With Pulmonary Hypertension in China

• Conditions: COPD; Pulmonary Hypertension

• Registration Number: NCT03185572
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary

Pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD). It is reported that over half of COPD patients develop pulmonary hypertension. COPD and pulmonary hypertension may have pathological or genetics interactions so that patients having both disorders tend to have poor prognosis. Echocardiography is widely used to detect pulmonary hypertension, but it's not accurate enough. Therefore, high-quality data reflecting the prevalence, disease course and outcome of pulmonary hypertension in COPD is very limited in China. The aim of the study is to detect pulmonary hypertension with right heart catheterization, describe its outcome in Chinese COPD patients and explore the underlying interaction mechanism.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-10
• Study First Submitted QC: 2017-06-12
• Last Update Submitted: 2017-06-13
• Study First Posted: 2017-06-14
• Last Update Posted: 2017-06-14
• Study Start: 2017-06-15
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1708

Inclusion Criteria

• Stable chronic obstructive pulmonary disease (COPD) patients

Exclusion Criteria

• Patients with other serious respiratory diseases
• Patients with pulmonary hypertension other than group 3
• Patients with right heart hypertrophy or dysfunction not caused by chronic obstructive pulmonary diseases
• Patients with limited life expectancy
• Patients with history of tracheal intubation or stoke, acute coronary syndrome in 6 months
• Psychopath or addict

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COPD exacerbations	3 years	total hospitalizations times due to COPD exacerbations

Secondary Outcome Measures

Name	Time	Method
modified British medical research council (mMRC) score	3 years	COPD symptom score
transplant-free survival rate	3 years	transplant-free survival rate in %
COPD Assessment Test (CAT) score	3 years	COPD symptom score
6 minutes walk distance	3 years	meters

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China