NCT03184727

Brief 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.

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
600

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2017

Completed
6 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 8, 2017

Last Update Submit

June 13, 2017

Conditions

COPDPulmonary Vascular DisorderRight Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    survival rate in %

    3 years

Secondary Outcomes (3)

  • COPD exacerbations

    3 year

  • GOLD degree

    3 year

  • NYHA degree

    3 year

Eligibility Criteria

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

stable COPD patients

You may qualify if:

  • stable COPD patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Institute and Fu Wai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum and blood cells

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveVentricular Dysfunction, Right

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jianguo He He, MD

CONTACT

80-10-88398060hejianguofw@163.com

Study Design

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

Study Record Dates

First Submitted

June 8, 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

CN(1)