NCT03185572

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,708

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

3.5 years

First QC Date

June 10, 2017

Last Update Submit

June 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • COPD exacerbations

    total hospitalizations times due to COPD exacerbations

    3 years

Secondary Outcomes (4)

  • modified British medical research council (mMRC) score

    3 years

  • COPD Assessment Test (CAT) score

    3 years

  • 6 minutes walk distance

    3 years

  • transplant-free survival rate

    3 years

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stable COPD patients

You may qualify if:

  • Stable chronic obstructive pulmonary disease (COPD) patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum and blood cells

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHypertensionVascular DiseasesCardiovascular Diseases

Central Study Contacts

Guohua Zhen, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Pulmonary Vascular Disease Center

Study Record Dates

First Submitted

June 10, 2017

First Posted

June 14, 2017

Study Start

June 15, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations