Registry for Chronic Obstructive Pulmonary Disease With Pulmonary Hypertension in China

COPD Clinical Trial

Official title:

The Prevalence, Disease Course, Prognosis and Interaction of Chronic Obstructive Pulmonary Disease With Pulmonary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03185572
• Other study ID #: 2016YFC1304401A
• Status: Recruiting
• Phase: N/A
• First received: June 10, 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: Guohua Zhen, MD
• Phone: 13517277794
• Email: guohuazhen[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1708
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Hypertension
• Hypertension, Pulmonary
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Hypertension

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

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	COPD exacerbations	total hospitalizations times due to COPD exacerbations	3 years
Secondary	modified British medical research council (mMRC) score	COPD symptom score	3 years
Secondary	COPD Assessment Test (CAT) score	COPD symptom score	3 years
Secondary	6 minutes walk distance	meters	3 years
Secondary	transplant-free survival rate	transplant-free survival rate in %	3 years