Registry for Chronic Obstructive Pulmonary Disease With P... | NCT03185572

Studies
Registry for Chronic Obstructive Pulmonary Disease With Pulmonary Hypertension in China

NCT03185572

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Unknown status

Last Update Posted

Jun 14, 2017Actual

Enrollment

1,708Estimated

Phase

Not provided

Conditions

COPD
Pulmonary Hypertension

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2017Estimated

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Jun 10, 2017

First Submission Date that Met QC Criteria

Jun 12, 2017

First Posted Date

Jun 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2017

Last Update Posted Date

Jun 14, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jianguo He, Chief of Pulmonary Vascular Disease Center, Chinese Academy of Medical Sciences, Fuwai HospitalPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,708Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
COPD exacerbations	total hospitalizations times due to COPD exacerbations	3 years

Secondary Outcomes

Measure	Description	Time Frame
modified British medical research council (mMRC) score	COPD symptom score	3 years
COPD Assessment Test (CAT) score	COPD symptom score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Stable COPD patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guohua Zhen, MD	Contact	13517277794		guohuazhen@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Recruiting	Wuhan	Hubei	430030	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided