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Pulmonary Vasculature and Right Heart Dysfunction in Chronic Obstructive Pulmonay Disease

Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03184727
Collaborator
(none)
600
Enrollment
1
Location
42.5
Anticipated Duration (Months)
14.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pulmonary Vasculature and Right Heart Dysfunction in Chronic Obstructive Pulmonay Disease
    Anticipated Study Start Date :
    Jun 15, 2017
    Anticipated Primary Completion Date :
    Dec 31, 2020
    Anticipated Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. All-cause mortality [3 years]

      survival rate in %

    Secondary Outcome Measures

    1. COPD exacerbations [3 year]

      total times

    2. GOLD degree [3 year]

      Ⅰ-Ⅳ according to the pulmonary function

    3. NYHA degree [3 year]

      Ⅰ-Ⅳ according to the symptom

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • stable COPD patients
    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cardiovascular Institute and Fu Wai Hospital Beijing Beijing China 100037

    Sponsors and Collaborators

    • Chinese Academy of Medical Sciences, Fuwai Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jianguo He, Chief of Pulmonary Vascular Disease Center, Chinese Academy of Medical Sciences, Fuwai Hospital
    ClinicalTrials.gov Identifier:
    NCT03184727
    Other Study ID Numbers:
    • 2016YFC1304405
    First Posted:
    Jun 14, 2017
    Last Update Posted:
    Jun 14, 2017
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ventricular Dysfunction
    Ventricular Dysfunction, Right
    Vascular Diseases

    Study Results

    No Results Posted as of Jun 14, 2017